Medical device recalls: April 2003
The FDA posted 95 medical device recall records in April 2003, from 45 recall events by 36 companies. 95 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
- Sedecal USA, Inc. · 3 events, 3 records
- Kinetic Concepts, Inc · 2 events, 6 records
- Boston Scientific Scimed · 2 events, 4 records
- Cryolife Inc · 2 events, 3 records
- Roche Diagnostics Corp. · 2 events, 3 records
- Abbott Laboratories HPD/ADD · 2 events, 2 records
- Abbott Laboratories, Inc · 2 events, 2 records
- I-Flow Corporation · 2 events, 2 records
FDA root cause
- Other · 95
Not yet classified (95)
The FDA has posted these records but has not published a class for them yet.
- Z-0649-03 · Sedecal USA, Inc. · posted Apr 25, 2003 · Terminated
Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.
- Z-0652-03 · Sedecal USA, Inc. · posted Apr 25, 2003 · Terminated
Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.
- Z-0781-03 · Ohio Medical Instrument Co Inc · posted Apr 25, 2003 · Terminated
The component was manufactured with an insufficient weld that could break during use.
- Z-0783-03 · General Electric Medical Systems Information Technology · posted Apr 25, 2003 · Terminated
There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Z-0784-03 · General Electric Medical Systems Information Technology · posted Apr 25, 2003 · Terminated
There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Z-0785-03 · General Electric Medical Systems Information Technology · posted Apr 25, 2003 · Terminated
There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Z-0786-03 · General Electric Medical Systems Information Technology · posted Apr 25, 2003 · Terminated
There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.
- Z-650/51-03 · Sedecal USA, Inc. · posted Apr 25, 2003 · Terminated
Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard
- Z-0782-03 · Abbott Laboratories HPD/ADD · posted Apr 24, 2003 · Terminated
Lot gives lower specimen results compared to results generated with other lots.
- Z-0753-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0754-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0755-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0756-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0757-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0758-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0759-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0760-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0761-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0762-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0763-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0764-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0765-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0766-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0767-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product has latex free symbol on package, yet contains latex components.
- Z-0768-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0769-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0770-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0771-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0772-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0773-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0774-03 · Windstone Medical, Inc. · posted Apr 22, 2003 · Terminated
Product contains latex, but not labeled as containing latex.
- Z-0775-03 · Guidant Corporation ACS · posted Apr 22, 2003 · Terminated
Complaints that the stents are being dislodged from the delivery system.
- Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 ↗Z-0776-03 · Boston Scientific Scimed · posted Apr 22, 2003 · Terminated
A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Z-0777-03 · Boston Scientific Scimed · posted Apr 22, 2003 · Terminated
A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Z-0778-03 · Boston Scientific Scimed · posted Apr 22, 2003 · Terminated
A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Z-0779-03 · 3m Health Care · posted Apr 22, 2003 · Terminated
Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
- Z-0780-03 · Gish Biomedical Inc · posted Apr 22, 2003 · Terminated
Two reports of leakage.
- Z-0741-03 · I-Flow Corporation · posted Apr 18, 2003 · Terminated
Overinfusion due to misassembly.
- Z-0742-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0743-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0744-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0745-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0746-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0747-03 · Tyco Healthcare/Kendall · posted Apr 18, 2003 · Terminated
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Z-0748-03 · Kinetic Concepts, Inc · posted Apr 18, 2003 · Terminated
Battery Failure/ Outgassing
- Z-0749-03 · Kinetic Concepts, Inc · posted Apr 18, 2003 · Terminated
Battery Failure/ Outgassing
- Z-0750-03 · Kinetic Concepts, Inc · posted Apr 18, 2003 · Terminated
Battery Failure/ Outgassing
- Z-0751-03 · Kinetic Concepts, Inc · posted Apr 18, 2003 · Terminated
Battery Failure/ Outgassing
- Z-0752-03 · Kinetic Concepts, Inc · posted Apr 18, 2003 · Terminated
Battery Failure/ Outgassing
- Z-0730-03 · Darex Container Products Div of W.R. Grace & Co. · posted Apr 17, 2003 · Terminated
Contaminated with epoxy chips.
- Z-0731-03 · Darex Container Products Div of W.R. Grace & Co. · posted Apr 17, 2003 · Terminated
Contaminated with epoxy chips.
- Z-0732-03 · C.R. Bard, Inc., Urological Division · posted Apr 17, 2003 · Terminated
There is a potential for package seals to be open after sterilization.
- Z-0734-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0735-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0736-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0737-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0738-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on thel catheter and result in the tip protector advancing through the catheter during use
- Z-0739-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0740-03 · Boston Scientific Corporation · posted Apr 17, 2003 · Terminated
Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use
- Z-0724-03 · Steris Corp · posted Apr 16, 2003 · Terminated
The defective device may restrict the flow of sterilant to the attached endoscope and affect the sterilization process of the scope.
- Z-0725-03 · Abbott Laboratories, Inc · posted Apr 16, 2003 · Terminated
Under certain operating conditions, smart wash feature disables with multiple samples.
- Z-0726-03 · Abbott Laboratories HPD/ADD · posted Apr 16, 2003 · Terminated
The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values
- Z-0727-03 · Siemens Medical Solutions USA, Inc. · posted Apr 16, 2003 · Terminated
ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
- Z-0728-03 · Endocare Inc · posted Apr 16, 2003 · Terminated
Device design failure, connectivity.
- Z-0721-03 · Abbott Laboratories, Inc · posted Apr 15, 2003 · Terminated
The autoprint feature allows the switch of patient IDs in remote cases.
- Z-0722-03 · Cryolife Inc · posted Apr 15, 2003 · Terminated
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
- Z-0723-03 · Cryolife Inc · posted Apr 15, 2003 · Terminated
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
- Z-0717-03 · Linvatec Corp DBA Linvatec/Hal · posted Apr 10, 2003 · Terminated
The Footswitch functions of the left and right foot pedals may be reversed in some units.
- Z-0718-03 · Kinetic Concepts, Inc · posted Apr 10, 2003 · Terminated
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
- Z-0719-03 · Cryolife Inc · posted Apr 10, 2003 · Terminated
Pre-processing cultures detected certain microorganisms in donor tissue.
- Z-0720-03 · Roche Diagnostics Corp. · posted Apr 10, 2003 · Terminated
Discrepancy between INR and the % Quick displayed on the meter.
- Z-0710-03 · Avanta Orthopaedics, Inc. · posted Apr 9, 2003 · Terminated
Wrong silicone elastomer used in construction.
- Z-0711-03 · Boston Scientific Scimed · posted Apr 9, 2003 · Terminated
The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
- Z-0712-03 · Sybron Dental Specialties · posted Apr 9, 2003 · Terminated
Moisture ingress into packaging of test strips may cause premature failure.
- Z-0713-03 · Datex-Ohmeda · posted Apr 9, 2003 · Terminated
Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
- Z-0714-03 · Datex-Ohmeda · posted Apr 9, 2003 · Terminated
Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
- Z-0715-03 · Roche Diagnostics Corp. · posted Apr 9, 2003 · Terminated
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
- Z-0716-03 · Roche Diagnostics Corp. · posted Apr 9, 2003 · Terminated
Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
- Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' . ↗Z-0298-03 · Terumo Cardiovascular Systems Corp · posted Apr 3, 2003 · Terminated
Heat exchanger may contain loose particulate matter
- Z-0299-03 · Biosound Esaote, Inc. · posted Apr 3, 2003 · Terminated
Excessive power output due to a faulty voltage controller.
- Z-0708-03 · Deroyal Surgical -Rose Hill · posted Apr 3, 2003 · Terminated
Non-sterile surgical medical device is labeled as sterile product.
- Z-0709-03 · I-Flow Corporation · posted Apr 3, 2003 · Terminated
Wrong component may result in over infusion of medications.
- Z-0686-03 · Misys Healthcare Systems · posted Apr 2, 2003 · Terminated
Patient results do not update properly when modified using on-line entry function.
- Z-0706-03 · Beckman Coulter Inc · posted Apr 2, 2003 · Terminated
Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
- Z-0707-03 · Cordis Corporation · posted Apr 2, 2003 · Terminated
The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
- Z-0696-03 · Mitek Worldwide · posted Apr 1, 2003 · Terminated
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.
- Z-0697-03 · Mitek Worldwide · posted Apr 1, 2003 · Terminated
Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm
- Z-0698-03 · Mitek Worldwide · posted Apr 1, 2003 · Terminated
Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm
- Z-0699-03 · Mitek Worldwide · posted Apr 1, 2003 · Terminated
Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
- Z-0700-03 · Biotronik Inc · posted Apr 1, 2003 · Terminated
Potential for battery to delivery less than full amount of energy.
- Z-0701-03 · Biotronik Inc · posted Apr 1, 2003 · Terminated
Potential for battery to delivery less than full amount of energy
- Z-0702-03 · Biotronik Inc · posted Apr 1, 2003 · Terminated
Potential for battery to delivery less than full amount of energy
- Z-0703-03 · Ciba Vision Corporation · posted Apr 1, 2003 · Terminated
The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
- Z-0704-03 · Midmark Corp · posted Apr 1, 2003 · Terminated
The pressure relief valve may fail to open properly.
- Z-0705-03 · Surgical Specialties Corp · posted Apr 1, 2003 · Terminated
size mislabeled on product handle
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.