Medical device recalls: May 2007
The FDA posted 76 medical device recall records in May 2007, from 40 recall events by 35 companies. 76 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
- Becton Dickinson & Company · 3 events, 3 records
- bioMerieux, Inc. · 2 events, 5 records
- B. Braun Medical, Inc. · 2 events, 3 records
- GE Medical Systems LLC · 2 events, 2 records
- Integra LifeSciences Corp. · 1 event, 6 records
- American Medical Systems · 1 event, 5 records
- Binax, Inc. dba IMPD · 1 event, 5 records
- GE Healthcare · 1 event, 5 records
FDA root cause
- Other · 73
- Nonconforming Material/Component · 2
- PMA · 1
Not yet classified (76)
The FDA has posted these records but has not published a class for them yet.
- Z-0818-2007 · B. Braun Medical, Inc. · posted May 31, 2007 · Terminated
Secondary infusion backs up into primary container.
- Z-0819-2007 · B. Braun Medical, Inc. · posted May 31, 2007 · Terminated
Secondary infusion backs up into primary container.
- Z-0833-2007 · Kensey Nash Corp · posted May 31, 2007 · Terminated
Insufficient wire sealing
- Z-0834-2007 · Kensey Nash Corp · posted May 31, 2007 · Terminated
Insufficient wire sealing
- Z-0835-2007 · Kensey Nash Corp · posted May 31, 2007 · Terminated
Insufficient wire sealing
- Z-0843-2007 · Merit Medical Systems, Inc. · posted May 31, 2007 · Terminated
Male luer in fluid administration sets may crack due to inadequate molding process
- Z-0844-2007 · Merit Medical Systems, Inc. · posted May 31, 2007 · Terminated
Male luer in fluid administration sets may crack due to inadequate molding process
- Z-0845-2007 · Merit Medical Systems, Inc. · posted May 31, 2007 · Terminated
Male luer in fluid administration sets may crack due to inadequate molding process
- Z-0846-2007 · Merit Medical Systems, Inc. · posted May 31, 2007 · Terminated
Male luer in fluid administration sets may crack due to inadequate molding process
- Z-0847-2007 · Merit Medical Systems, Inc. · posted May 31, 2007 · Terminated
Male luer in fluid administration sets may crack due to inadequate molding process
- Z-0820-2007 · Ortho-Clinical Diagnostics · posted May 26, 2007 · Terminated
Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
- Z-0495-2007 · Bausch & Lomb Inc · posted May 24, 2007 · Terminated
The cutter tip could break during a procedure
- Z-0496-2007 · Bausch & Lomb Inc · posted May 24, 2007 · Terminated
The cutter tip could break during a procedure
- Z-0807-2007 · C P Medical · posted May 24, 2007 · Terminated
Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
- Z-0808-2007 · C P Medical · posted May 24, 2007 · Terminated
Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
- Z-0809-2007 · C P Medical · posted May 24, 2007 · Terminated
Potential for sterility of product to be compromised. Suture package seals incomplete or missing.
- Z-0813-2007 · Becton Dickinson & Company · posted May 24, 2007 · Terminated
Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.
- Z-0827-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0828-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0829-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0830-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0831-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0832-2007 · Integra LifeSciences Corp. · posted May 24, 2007 · Terminated
Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall…
- Z-0838-2007 · Becton Dickinson & Company · posted May 24, 2007 · Terminated
Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)
- Z-0709-2007 · Abbott Diabetes Care, Inc. · posted May 23, 2007 · Terminated
If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.
- Z-0822-2007 · Binax, Inc. dba IMPD · posted May 23, 2007 · Terminated
Tip of the foam swab could detach from the shaft causing injury to the patient.
- Z-0823-2007 · Binax, Inc. dba IMPD · posted May 23, 2007 · Terminated
Tip of the foam swab could detach from the shaft causing injury to the patient.
- Z-0824-2007 · Binax, Inc. dba IMPD · posted May 23, 2007 · Terminated
Tip of the foam swab could detach from the shaft causing injury to the patient.
- Z-0825-2007 · Binax, Inc. dba IMPD · posted May 23, 2007 · Terminated
Tip of the foam swab could detach from the shaft causing injury to the patient.
- Z-0826-2007 · Binax, Inc. dba IMPD · posted May 23, 2007 · Terminated
Tip of the foam swab could detach from the shaft causing injury to the patient.
- Z-0817-2007 · Medtronic Neuromodulation · posted May 22, 2007 · Terminated
Medtronic pH 1.07 buffer solution lot #2610596 was mislableled.
- Z-0821-2007 · GE Medical Systems LLC · posted May 22, 2007 · Terminated
When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
- Z-0814-2007 · bioMerieux, Inc. · posted May 18, 2007 · Terminated
BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.
- Z-0815-2007 · GE Medical Systems LLC · posted May 18, 2007 · Terminated
To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.
- Z-0816-2007 · Instrumentarium Dental, Inc. · posted May 18, 2007 · Terminated
There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.
- Z-0810-2007 · Roche Diagnostics Corp. · posted May 16, 2007 · Terminated
Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
- Z-0811-2007 · Biomet 3i · posted May 16, 2007 · Terminated
The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
- Z-0812-2007 · Diagnostica Stago, Inc. · posted May 16, 2007 · Terminated
Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
- Z-0802-2007 · GE Healthcare · posted May 15, 2007 · Terminated
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Z-0803-2007 · GE Healthcare · posted May 15, 2007 · Terminated
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Z-0804-2007 · GE Healthcare · posted May 15, 2007 · Terminated
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Z-0805-2007 · GE Healthcare · posted May 15, 2007 · Terminated
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Z-0806-2007 · GE Healthcare · posted May 15, 2007 · Terminated
Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Z-0796-2007 · Arjo, Inc. · posted May 11, 2007 · Terminated
The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
- Z-0797-2007 · Arjo, Inc. · posted May 11, 2007 · Terminated
The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
- Z-0798-2007 · Arjo, Inc. · posted May 11, 2007 · Terminated
The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
- Z-0799-2007 · Arjo, Inc. · posted May 11, 2007 · Terminated
The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
- Z-0800-2007 · 3M Espe Dental Products · posted May 11, 2007 · Terminated
Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
- Z-0801-2007 · BioHorizons Implant Systems Inc · posted May 11, 2007 · Terminated
Dental implant system is missing ball attachment system.
- Z-0777-2007 · Becton Dickinson & Company · posted May 10, 2007 · Terminated
The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.
- Z-0784-2007 · Datex - Ohmeda, Inc · posted May 10, 2007 · Terminated
There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
- Z-0794-2007 · Boston Scientific · posted May 10, 2007 · Terminated
One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06.
- Z-0795-2007 · Ethicon, Inc. · posted May 10, 2007 · Terminated
The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
- Z-0785-2007 · American Medical Systems · posted May 9, 2007 · Terminated
The carton labeling does not match the product packaged inside.
- Z-0786-2007 · American Medical Systems · posted May 9, 2007 · Terminated
The carton labeling does not match the product packaged inside.
- Z-0787-2007 · American Medical Systems · posted May 9, 2007 · Terminated
The carton labeling does not match the product packaged inside.
- Z-0788-2007 · American Medical Systems · posted May 9, 2007 · Terminated
The carton labeling does not match the product packaged inside.
- Z-0789-2007 · American Medical Systems · posted May 9, 2007 · Terminated
The carton labeling does not match the product packaged inside.
- Z-0790-2007 · Abbott Laboratories, Inc · posted May 9, 2007 · Terminated
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Z-0791-2007 · Abbott Laboratories, Inc · posted May 9, 2007 · Terminated
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Z-0792-2007 · Abbott Laboratories, Inc · posted May 9, 2007 · Terminated
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Z-0793-2007 · Ciba Vision Corporation · posted May 9, 2007 · Terminated
Base curve of the lenses do not meet specification.
- Z-0771-2007 · Toshiba American Med Sys Inc · posted May 5, 2007 · Terminated
Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC…
- Z-0772-2007 · Graham Field Atlanta · posted May 5, 2007 · Terminated
The caster bolt stem/screw may loosen over time causing the wheel to come off.
- Z-0781-2007 · Smith & Nephew, Inc Endoscopy Division · posted May 5, 2007 · Terminated
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
- Z-0782-2007 · Smith & Nephew, Inc Endoscopy Division · posted May 5, 2007 · Terminated
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
- Z-0783-2007 · B. Braun Medical, Inc. · posted May 5, 2007 · Terminated
The integrity of the sterile product barrier may be compromised
- Z-0770-2007 · Custom Ultrasonics, Inc. · posted May 4, 2007 · Terminated
The device was marketed without a 510k
- Z-0780-2007 · Orthopedic Systems Inc · posted May 4, 2007 · Terminated
Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.
- Z-0773-2007 · bioMerieux, Inc. · posted May 3, 2007 · Terminated
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Z-0774-2007 · bioMerieux, Inc. · posted May 3, 2007 · Terminated
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Z-0775-2007 · bioMerieux, Inc. · posted May 3, 2007 · Terminated
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Z-0776-2007 · bioMerieux, Inc. · posted May 3, 2007 · Terminated
Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.
- Z-0778-2007 · Instrumentation Laboratory Co. · posted May 3, 2007 · Terminated
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
- Z-0779-2007 · American Diagnostica, Inc. · posted May 3, 2007 · Terminated
Stability of product not assured. An increase of clotting time for both normal and abnormal plasmas
- Z-0758-2007 · Teleflex Medical · posted May 2, 2007 · Terminated
The MRI Battery is out of specification for its magnetic content.
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.