Medical device recalls: June 2003
The FDA posted 57 medical device recall records in June 2003, from 42 recall events by 38 companies. 57 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 · 4 events, 12 records
- Misys Healthcare Systems · 2 events, 2 records
- GE OEC Medical Systems,Inc · 1 event, 3 records
- Cryolife Inc · 1 event, 2 records
- Electric Mobility Corp · 1 event, 2 records
- Implant Innovations, Inc. · 1 event, 2 records
- Merit Medical Systems, Inc · 1 event, 2 records
- System 02 Inc · 1 event, 2 records
FDA root cause
- Other · 55
- Process design · 1
- Device Design · 1
Not yet classified (57)
The FDA has posted these records but has not published a class for them yet.
- Z-0952-03 · Standard Imaging Inc. · posted Jun 27, 2003 · Terminated
Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors.
- Z-0953-03 · The OR Group,Inc. · posted Jun 27, 2003 · Terminated
Foot Stirrups may detach from mount when user is locking system
- Z-0954-03 · Draeger Medical, Inc. · posted Jun 27, 2003 · Terminated
software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
- Z-0955-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-0956-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-0957-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-0958-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-0959-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-1134-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-1135-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-1136-03 · Abbott Laboratories HPD/ADD · posted Jun 27, 2003 · Terminated
The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Z-0911-03 · Bayer HealthCare LLC, Diagnostics Div · posted Jun 21, 2003 · Terminated
Analyzer will produce erroneous results due to missing grounding strap.
- Z-0943-03 · Disc Orthopaedic Technologies Inc · posted Jun 21, 2003 · Terminated
The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
- Z-0944-03 · Safco Dental Supply Co. Inc. · posted Jun 21, 2003 · Terminated
The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
- Z-0945-03 · GE OEC Medical Systems,Inc · posted Jun 21, 2003 · Terminated
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
- Z-0946-03 · GE OEC Medical Systems,Inc · posted Jun 21, 2003 · Terminated
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
- Z-0947-03 · GE OEC Medical Systems,Inc · posted Jun 21, 2003 · Terminated
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
- Z-0948-03 · Pioneer Surgical Technology · posted Jun 21, 2003 · Terminated
Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
- Z-0949-03 · Alphatec Mfg Inc · posted Jun 21, 2003 · Terminated
Laser marking is wrong on bone screws, says 40 and is 45 mm long.
- Z-0950-03 · Binding Site Inc The · posted Jun 21, 2003 · Terminated
Risk of false positives.
- Z-0923-03 · Implant Innovations, Inc. · posted Jun 17, 2003 · Terminated
Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
- Z-0924-03 · Implant Innovations, Inc. · posted Jun 17, 2003 · Terminated
Some 8mm OsseoFix drills may be incorrectly laser marked as 4mm OsseoFix drills.
- Z-0926-03 · Misys Healthcare Systems · posted Jun 17, 2003 · Terminated
Two clients reported Quality Assurance dates could not be entered after 5/19/03.
- Z-0928-03 · Ventana Medical Systems Inc · posted Jun 17, 2003 · Terminated
Kit does not stain tissues properly.
- Z-0931-03 · Rehabilicare · posted Jun 17, 2003 · Terminated
If there was a short, excessive heat could have been generated in the transformer due to the use of the wrong fuse.
- Z-0934-03 · Abbott Laboratories HPD/ADD · posted Jun 17, 2003 · Terminated
The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL
- Z-0936-03 · Abbott Laboratories HPD/ADD · posted Jun 17, 2003 · Terminated
The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
- Z-0938-03 · Cryolife Inc · posted Jun 17, 2003 · Terminated
Microorganisms detected in associated allografts.
- Z-0939-03 · Cryolife Inc · posted Jun 17, 2003 · Terminated
Microorganisms detected in associated allografts.
- Z-0868-03 · Stryker Medical · posted Jun 12, 2003 · Terminated
A wire may break at the crimp and present a potential electric shock hazard.
- Z-0922-03 · Cytyc Corporation · posted Jun 12, 2003 · Terminated
Microscope Slides contaminated with fungal material
- Z-0925-03 · Venetec Intl Inc · posted Jun 12, 2003 · Terminated
Set tubing disconnected from the male luer lock during use on patients. Misassembled.
- Z-0927-03 · Portex, Inc · posted Jun 12, 2003 · Terminated
May have incorrectly printed graduation markings along the tube shaft.
- Z-0929-03 · System 02 Inc · posted Jun 12, 2003 · Terminated
System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'
- Z-0930-03 · System 02 Inc · posted Jun 12, 2003 · Terminated
System 02 oxygen flow rate found to be inadequate and Rejuv02 Home Oxygen Bar contains 'Adulterated Labeling.'
- Z-0932-03 · Fujifilm Medical System USA, Inc. · posted Jun 12, 2003 · Terminated
Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan
- Z-0933-03 · Braun,B Medical Inc · posted Jun 12, 2003 · Terminated
possible leakage
- Z-0935-03 · Sanarus Medical Inc · posted Jun 12, 2003 · Terminated
Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
- Z-0940-03 · Medtronic Physio Control Corp · posted Jun 12, 2003 · Terminated
Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
- Z-0941-03 · Cordis Corporation · posted Jun 12, 2003 · Terminated
Reports of broken or separated tips of the catheter sheath introducers.
- Z-0942-03 · Cardinal Health · posted Jun 12, 2003 · Terminated
The product was shipped prior to being sterilized.
- Z-0905-03 · Canon USA Inc · posted Jun 5, 2003 · Terminated
Imaging archive system software mismatches images and patient names.
- Z-0906-03 · Fresenius Hemocare, Inc. · posted Jun 5, 2003 · Terminated
Sterility may be compromised
- Z-0907-03 · Immedica Inc · posted Jun 5, 2003 · Terminated
Mislabeled; wrong identification number on pin.
- Z-0908-03 · Getinge/Castle, Inc. · posted Jun 5, 2003 · Terminated
Hot water may splash from the washer chamber creating a burn hazard.
- Z-0909-03 · Electric Mobility Corp · posted Jun 5, 2003 · Terminated
The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
- Z-0910-03 · Electric Mobility Corp · posted Jun 5, 2003 · Terminated
The plastic tires may shatter if the tire is over-inflated and could cause serious injury.
- Z-0912-03 · Merit Medical Systems, Inc · posted Jun 5, 2003 · Terminated
Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
- Z-0913-03 · Merit Medical Systems, Inc · posted Jun 5, 2003 · Terminated
Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
- Z-0914-03 · Abbott Laboratories HPD/ADD · posted Jun 5, 2003 · Terminated
IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
- Z-0915-03 · Abbott Laboratories HPD/ADD · posted Jun 5, 2003 · Terminated
IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
- Z-0916-03 · Datascope Corp · posted Jun 5, 2003 · Terminated
10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
- Z-0917-03 · Roche Molecular Systems Inc · posted Jun 5, 2003 · Terminated
A false positive result may be reported.
- Z-0918-03 · Surgical Specialties Puerto Rico, Inc. · posted Jun 5, 2003 · Terminated
Incorrect handle was used in the manufacture of product 52-2761
- Z-0919-03 · Ortho-Clinical Diagnostics · posted Jun 5, 2003 · Terminated
Slides may exhibit random, elevated imprecision of results.
- Z-0920-03 · Misys Healthcare Systems · posted Jun 5, 2003 · Terminated
Urgent care STAT reports are not printing in a timely fashion.
- Z-0904-03 · Smith and Nephew Wound Management (La Jolla) · posted Jun 4, 2003 · Terminated
Did not meet finished device specifications for the DNA criteria.
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.