Medical device recalls: March 2006
The FDA posted 127 medical device recall records in March 2006, from 43 recall events by 40 companies. 127 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Baxter Healthcare Corp. · 3 events, 35 records
- Zimmer Inc. · 2 events, 5 records
- Stryker Instruments Div. of Stryker Corporation · 1 event, 9 records
- Endologix Inc · 1 event, 8 records
- Kerr Corp · 1 event, 8 records
- Regeneration Technologies, Inc. · 1 event, 6 records
- Bard Access Systems, Inc · 1 event, 4 records
- Bayer Healthcare, LLC (Diagnostics Division) · 1 event, 4 records
FDA root cause
- Other · 125
- Software design · 1
- Process control · 1
Not yet classified (127)
The FDA has posted these records but has not published a class for them yet.
- Z-0554-06 · Stryker Medical · posted Mar 31, 2006 · Terminated
The bed exit may not alarm as appropriate.
- Z-0555-06 · Stryker Medical · posted Mar 31, 2006 · Terminated
The bed exit may not alarm as appropriate.
- Z-0533-06 · Toshiba American Med Sys Inc · posted Mar 29, 2006 · Terminated
When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the…
- Z-0679-06 · Baxter Healthcare Renal Div · posted Mar 29, 2006 · Terminated
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor…
- Z-0680-06 · Baxter Healthcare Renal Div · posted Mar 29, 2006 · Terminated
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor…
- Z-0681-06 · Baxter Healthcare Renal Div · posted Mar 29, 2006 · Terminated
Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor…
- Z-0682-06 · Bayer Healthcare, LLC (Diagnostics Division) · posted Mar 29, 2006 · Terminated
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or…
- Z-0683-06 · Bayer Healthcare, LLC (Diagnostics Division) · posted Mar 29, 2006 · Terminated
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or…
- Z-0684-06 · Bayer Healthcare, LLC (Diagnostics Division) · posted Mar 29, 2006 · Terminated
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or…
- Z-0685-06 · Bayer Healthcare, LLC (Diagnostics Division) · posted Mar 29, 2006 · Terminated
When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or…
- Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110 ↗Z-0694-06 · Fisher & Paykel Healthcare Inc · posted Mar 29, 2006 · Terminated
Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111 ↗Z-0695-06 · Fisher & Paykel Healthcare Inc · posted Mar 29, 2006 · Terminated
Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT210 ↗Z-0696-06 · Fisher & Paykel Healthcare Inc · posted Mar 29, 2006 · Terminated
Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211 ↗Z-0697-06 · Fisher & Paykel Healthcare Inc · posted Mar 29, 2006 · Terminated
Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.
- Z-0686-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0687-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0688-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0689-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0690-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0691-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0692-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0693-06 · Kerr Corp · posted Mar 28, 2006 · Terminated
The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Z-0698-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0699-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0700-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0701-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0702-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0703-06 · Regeneration Technologies, Inc. · posted Mar 28, 2006 · Terminated
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including…
- Z-0677-06 · St. Jude Medical / Daig Division · posted Mar 25, 2006 · Terminated
Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
- Z-0678-06 · Shelhigh, Inc. · posted Mar 25, 2006 · Terminated
Unapproved Device-Distribution of an unapproved device into interstate commerce.
- Z-0625-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0626-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0627-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0628-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0629-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0630-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0631-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0632-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0633-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0634-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0635-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0636-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0637-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0638-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0639-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0640-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0641-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0642-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0643-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0644-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0645-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0646-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0647-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0648-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0649-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0650-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0651-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0652-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0653-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0654-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0655-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0656-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0657-06 · Baxter Healthcare Corp. · posted Mar 24, 2006 · Terminated
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Z-0673-06 · International Technidyne Corp · posted Mar 23, 2006 · Terminated
Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product.
- Z-0674-06 · Cook Urological, Inc. · posted Mar 23, 2006 · Terminated
Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications,…
- Z-0675-06 · American Medical Systems · posted Mar 23, 2006 · Terminated
Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.
- Z-0676-06 · Alfa Wassermann, Inc · posted Mar 23, 2006 · Terminated
Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.
- Z-0589-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0590-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0591-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0592-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0593-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0594-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0595-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0596-06 · Endologix Inc · posted Mar 22, 2006 · Terminated
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Z-0662-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0663-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0664-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0665-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0666-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0667-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0668-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0669-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0670-06 · Stryker Instruments Div. of Stryker Corporation · posted Mar 21, 2006 · Terminated
The catheter tubing included in the kit may break during removal.
- Z-0671-06 · Zimmer Inc. · posted Mar 21, 2006 · Terminated
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
- Z-0672-06 · Zimmer Inc. · posted Mar 21, 2006 · Terminated
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
- Z-0770-06 · Zimmer Inc. · posted Mar 21, 2006 · Terminated
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
- Z-0771-06 · Zimmer Inc. · posted Mar 21, 2006 · Terminated
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
- Z-0658-06 · Smiths Medical MD, Inc. · posted Mar 18, 2006 · Terminated
Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Z-0659-06 · Smiths Medical MD, Inc. · posted Mar 18, 2006 · Terminated
Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Z-0660-06 · Smiths Medical MD, Inc. · posted Mar 18, 2006 · Terminated
Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Z-0661-06 · Masimo Corporation · posted Mar 18, 2006 · Terminated
Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a…
- Z-0707-06 · Ev3, Inc · posted Mar 18, 2006 · Terminated
Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.
- Z-0541-06 · Bard Access Systems, Inc · posted Mar 16, 2006 · Terminated
Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions,…
- Z-0542-06 · Bard Access Systems, Inc · posted Mar 16, 2006 · Terminated
Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions,…
- Z-0543-06 · Bard Access Systems, Inc · posted Mar 16, 2006 · Terminated
Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions,…
- Z-0544-06 · Bard Access Systems, Inc · posted Mar 16, 2006 · Terminated
Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions,…
- Z-0612-06 · Baxter Healthcare Corp. · posted Mar 16, 2006 · Terminated
A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
- Z-0604-06 · Abbott Diabetes Care, Inc. · posted Mar 15, 2006 · Terminated
The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
- Z-0605-06 · Abbott Diabetes Care, Inc. · posted Mar 15, 2006 · Terminated
The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
- Z-0606-06 · Biogenex Laboratories · posted Mar 15, 2006 · Terminated
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Z-0607-06 · Biogenex Laboratories · posted Mar 15, 2006 · Terminated
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Z-0608-06 · Biogenex Laboratories · posted Mar 15, 2006 · Terminated
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Z-0609-06 · Biogenex Laboratories · posted Mar 15, 2006 · Terminated
Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.
- Z-0610-06 · Depuy Mitek, a Johnson & Johnson Co. · posted Mar 15, 2006 · Terminated
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- Z-0611-06 · Depuy Mitek, a Johnson & Johnson Co. · posted Mar 15, 2006 · Terminated
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
- Z-0613-06 · BD Opthalmic Systems · posted Mar 15, 2006 · Terminated
Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife
- Z-0622-06 · Fujifilm Medical System USA, Inc. · posted Mar 15, 2006 · Terminated
Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
- Z-0624-06 · Abbott Health Products, Inc. · posted Mar 15, 2006 · Terminated
Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material. An Important Product Information Letter with technical information…
- Z-0598-06 · Orthohelix Surgical Designs Inc · posted Mar 9, 2006 · Terminated
Screwdriver pilot taper tip can break during surgery.
- Z-0600-06 · Cook, Inc. · posted Mar 9, 2006 · Terminated
The side of the boxes give incorrect sizes for these stents. The label front is correct.
- Z-0601-06 · Hospira Inc · posted Mar 9, 2006 · Terminated
Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
- Z-0602-06 · Straumann Manufacturing Inc. · posted Mar 9, 2006 · Terminated
Pilot drills may not fully extend through drill guide in template products
- Z-0603-06 · Straumann Manufacturing Inc. · posted Mar 9, 2006 · Terminated
Pilot drills may not fully extend through drill guide in template products
- Z-0584-06 · I-Flow Corporation · posted Mar 7, 2006 · Terminated
The sterile pack may contain the wrong infusion pump inside.
- Z-0585-06 · I-Flow Corporation · posted Mar 7, 2006 · Terminated
The sterile pack may contain the wrong infusion pump inside.
- Z-0597-06 · Zimmer Inc. · posted Mar 7, 2006 · Terminated
Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.
- Z-0599-06 · Baxter Healthcare Corp. · posted Mar 7, 2006 · Terminated
The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
- Z-0565-06 · Inovise Medical, Inc. · posted Mar 3, 2006 · Terminated
Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.
- Z-0583-06 · Beckman Coulter Inc · posted Mar 3, 2006 · Terminated
The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
- Z-0586-06 · B. Braun Medical Inc · posted Mar 3, 2006 · Terminated
B. Braun Medical has been notified by the manufacturer of the product (Stedim) that a small percentage of the lots leak from the set port when the set port is opened. The leak was identified by Stedim to be due to the incorrect placement of a septum in the…
- Z-0587-06 · Inovel LLC · posted Mar 3, 2006 · Terminated
Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number
- Z-0545-06 · Lumenis Inc. · posted Mar 2, 2006 · Terminated
The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
- Z-0623-06 · Cardiac Science Corporation · posted Mar 2, 2006 · Terminated
Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
- Z-0575-06 · Gish Biomedical Inc · posted Mar 1, 2006 · Terminated
The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
- Z-0579-06 · Praxair Distribution Inc. · posted Mar 1, 2006 · Terminated
The units may experience a delay in oxygen flow upon initial actuation.
- Z-0580-06 · Praxair Distribution Inc. · posted Mar 1, 2006 · Terminated
The units may experience a delay in oxygen flow upon initial actuation.
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.