Medical device recalls: February 2004
The FDA posted 38 medical device recall records in February 2004, from 26 recall events by 23 companies. 38 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
- Abbott Laboratories HPD/ADD/GPRD · 2 events, 6 records
- Cryolife Inc · 2 events, 2 records
- Scion Cardio-Vascular, Inc. · 2 events, 2 records
- Laerdal Medical Corporation · 1 event, 4 records
- Stryker Medical · 1 event, 3 records
- Instrumentation Industries Inc · 1 event, 2 records
- Siemens Medical Solutions USA, Inc · 1 event, 2 records
- U&I America · 1 event, 2 records
FDA root cause
- Other · 38
Not yet classified (38)
The FDA has posted these records but has not published a class for them yet.
- Z-0554-04 · Scion Cardio-Vascular, Inc. · posted Feb 27, 2004 · Terminated
Possible difficulty for the user in opening the stone retrieval basket.
- Z-0555-04 · Instrumentation Industries Inc · posted Feb 27, 2004 · Terminated
possible external debris in the on/off plunger.
- Z-0556-04 · Instrumentation Industries Inc · posted Feb 27, 2004 · Terminated
possible external debris in the on/off plunger.
- Z-0557-04 · Scion Cardio-Vascular, Inc. · posted Feb 27, 2004 · Terminated
The firm received field complaints that it was difficult to open the stone retrieval basket during use.
- Z-0558-04 · U&I America · posted Feb 27, 2004 · Terminated
Reports of hex driver tips breaking off or becoming worn or stripped.
- Z-0559-04 · U&I America · posted Feb 27, 2004 · Terminated
Reports of hex driver tips breaking off or becoming worn or stripped.
- Z-0561-04 · Pioneer Surgical Technology · posted Feb 27, 2004 · Terminated
Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
- Z-0562-04 · C.R. Bard, Inc., Urological Division · posted Feb 27, 2004 · Terminated
The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
- Z-0550-04 · Abbott Laboratories Diagnostic Div · posted Feb 26, 2004 · Terminated
Low results due to contaminant.
- Z-0547-04 · Weck · posted Feb 25, 2004 · Terminated
Malformation of the Hem-o-lok SMX clip.
- Z-0548-04 · Cryolife Inc · posted Feb 25, 2004 · Terminated
As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
- Z-0549-04 · Becton Dickinson & Company · posted Feb 25, 2004 · Terminated
A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.
- Z-0541-04 · Magnivision, Inc. · posted Feb 24, 2004 · Terminated
Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.
- Z-0542-04 · Hardy Media Inc Dba Hardy Diag · posted Feb 24, 2004 · Terminated
Mislabeled.
- Z-0543-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 24, 2004 · Terminated
18 gauge needles in Central Venous Catheter kits may be partially occluded.
- Z-0544-04 · DeRoyal Surgical Tray · posted Feb 24, 2004 · Terminated
Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
- Z-0539-04 · Staar Surgical Co Inc · posted Feb 18, 2004 · Terminated
Risk of hyperopic refractive changes.
- Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 ↗Z-0538-04 · Welch Allyn Protocol, Inc · posted Feb 13, 2004 · Terminated
Potential failure to audibly alarm due to speaker hardware component failure.
- Z-0537-04 · Richard Wolf Medical Instruments Corp. · posted Feb 11, 2004 · Terminated
If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
- Z-0516-04 · Cryolife Inc · posted Feb 10, 2004 · Terminated
The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
- Z-0517-04 · Laerdal Medical Corporation · posted Feb 10, 2004 · Terminated
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
- Z-0518-04 · Laerdal Medical Corporation · posted Feb 10, 2004 · Terminated
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
- Z-0519-04 · Laerdal Medical Corporation · posted Feb 10, 2004 · Terminated
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
- Z-0520-04 · Laerdal Medical Corporation · posted Feb 10, 2004 · Terminated
Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
- Z-0521-04 · Siemens Medical Solutions USA, Inc · posted Feb 10, 2004 · Terminated
tissue roll can become magnetic
- Z-0522-04 · Siemens Medical Solutions USA, Inc · posted Feb 10, 2004 · Terminated
tissue roll can become magnetic
- Z-0523-04 · Medtronic, Inc. · posted Feb 10, 2004 · Terminated
Catheter distal tip may separate
- Z-0524-04 · Stryker Medical · posted Feb 10, 2004 · Terminated
A potential shock hazard exists if the night light is damaged.
- Z-0525-04 · Stryker Medical · posted Feb 10, 2004 · Terminated
A potential shock hazard exists if the night light is damaged.
- Z-0526-04 · Stryker Medical · posted Feb 10, 2004 · Terminated
A potential shock hazard exists if the night light is damaged.
- Z-0527-04 · GVI Technology Partners · posted Feb 10, 2004 · Terminated
Due to limitations in the operating software, the acquired scan may not be processed properly.
- Z-0531-04 · Medtronic MiniMed · posted Feb 10, 2004 · Terminated
A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
- Z-0507-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 4, 2004 · Terminated
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Z-0508-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 4, 2004 · Terminated
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Z-0509-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 4, 2004 · Terminated
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. % Recovery incorrect.
- Z-0510-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 4, 2004 · Terminated
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Z-0511-04 · Abbott Laboratories HPD/ADD/GPRD · posted Feb 4, 2004 · Terminated
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Z-0512-04 · Stockwell Scientific Inc · posted Feb 4, 2004 · Terminated
Tubes are brittle and break during centerfuging specimens.
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.