Medical device recalls: October 2004
The FDA posted 59 medical device recall records in October 2004, from 43 recall events by 41 companies. 59 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
- bioMerieux · 2 events, 3 records
- Dade Behring , Inc. · 2 events, 2 records
- Siemens Medical Solutions USA, Inc · 1 event, 5 records
- Advanced Bionics · 1 event, 3 records
- Becton Dickinson & Company · 1 event, 3 records
- Merit Medical Systems, Inc · 1 event, 3 records
- Thomas Medical Products Inc · 1 event, 3 records
- ABX Diagnostics Inc · 1 event, 2 records
FDA root cause
- Other · 58
- Packaging process control · 1
Not yet classified (59)
The FDA has posted these records but has not published a class for them yet.
- Z-0047-05 · PerkinElmer LAS Inc · posted Oct 28, 2004 · Terminated
The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly…
- Z-0048-05 · Merit Medical Systems, Inc · posted Oct 28, 2004 · Terminated
Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Z-0049-05 · Merit Medical Systems, Inc · posted Oct 28, 2004 · Terminated
Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Z-0050-05 · Merit Medical Systems, Inc · posted Oct 28, 2004 · Terminated
Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Z-0051-05 · Advanced Sterilization Products · posted Oct 28, 2004 · Terminated
Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
- Z-0052-05 · Becton Dickinson & Company · posted Oct 28, 2004 · Terminated
"Please be aware tht this not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB…
- Z-0053-05 · bioMerieux · posted Oct 28, 2004 · Terminated
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
- Z-0054-05 · bioMerieux · posted Oct 28, 2004 · Terminated
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
- Z-0055-05 · Fujifilm Medical System USA, Inc. · posted Oct 28, 2004 · Terminated
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.
- Z-0056-05 · Thomas Medical Products Inc · posted Oct 28, 2004 · Terminated
Sheaths may fracture if exposed to excess fluorescent light
- Z-0057-05 · Thomas Medical Products Inc · posted Oct 28, 2004 · Terminated
Sheaths may fracture if exposed to excess fluorescent light
- Z-0058-05 · Thomas Medical Products Inc · posted Oct 28, 2004 · Terminated
Sheaths may fracture if exposed to excess fluorescent light
- Z-0059-05 · Arrow International Inc · posted Oct 28, 2004 · Terminated
Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK
- Z-0060-05 · K C Pharmaceuticals Inc · posted Oct 28, 2004 · Terminated
Routine testing indicates product does not meet the expiration date in all cases.
- Z-1602-05 · Becton Dickinson & Company · posted Oct 28, 2004 · Terminated
"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in…
- Z-1603-05 · Becton Dickinson & Company · posted Oct 28, 2004 · Terminated
"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias…
- Z-0040-05 · Zimmer Spine, Inc. · posted Oct 23, 2004 · Terminated
To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of…
- Z-0041-05 · Linvatec Corp. · posted Oct 23, 2004 · Terminated
The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
- Z-0042-05 · Dade Behring , Inc. · posted Oct 23, 2004 · Terminated
APTT determinations when using affected rotors may lead to incorrectly shortened times
- Z-0043-05 · bioMerieux · posted Oct 23, 2004 · Terminated
The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
- Z-0044-05 · Advanced Bionics · posted Oct 23, 2004 · Terminated
All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
- Z-0045-05 · Advanced Bionics · posted Oct 23, 2004 · Terminated
All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
- Z-0046-05 · Advanced Bionics · posted Oct 23, 2004 · Terminated
All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
- Z-0031-05 · Weck · posted Oct 22, 2004 · Terminated
The jaws may break during clip loading or clip application.
- Z-0032-05 · Siemens Medical Solutions USA, Inc · posted Oct 22, 2004 · Terminated
possible error calculating valve area with the AXIOM Sensis
- Z-0033-05 · Siemens Medical Solutions USA, Inc · posted Oct 22, 2004 · Terminated
possible error calculating valve area with the AXIOM Sensis
- Z-0034-05 · Siemens Medical Solutions USA, Inc · posted Oct 22, 2004 · Terminated
possible error calculating valve area with the AXIOM Sensis
- Z-0035-05 · Siemens Medical Solutions USA, Inc · posted Oct 22, 2004 · Terminated
possible error calculating valve area with the AXIOM Sensis
- Z-0036-05 · Siemens Medical Solutions USA, Inc · posted Oct 22, 2004 · Terminated
possible error calculating valve area with the AXIOM Sensis
- Z-0037-05 · 3M Company / Medical Division · posted Oct 22, 2004 · Terminated
Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
- Z-0038-05 · Kinetic Concepts, Inc · posted Oct 22, 2004 · Terminated
The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.
- Z-0039-05 · Medrad Inc · posted Oct 22, 2004 · Terminated
Sterility can be compromised by a component tearing the outer packaging
- Z-0028-05 · Ciba Vision Corporation · posted Oct 21, 2004 · Terminated
Stability tests at 24 months revealed failing results for disinfection efficacy.
- Z-0029-05 · Implant Innovations, Inc. · posted Oct 21, 2004 · Terminated
The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
- Z-0030-05 · General Electric Medical Systems Information Technology · posted Oct 21, 2004 · Terminated
The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station…
- Z-0023-05 · Stryker Medical · posted Oct 20, 2004 · Terminated
Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop.
- Z-0024-05 · Remel, Inc. · posted Oct 20, 2004 · Terminated
The product does not perform as intended with some quality control organisms (Haemophilus influenzae)
- Z-0025-05 · Becton Dickinson & Co. · posted Oct 20, 2004 · Terminated
Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
- Z-0026-05 · Cryolife Inc · posted Oct 20, 2004 · Terminated
A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
- Z-0020-05 · Stryker Instruments, Instruments Div. · posted Oct 19, 2004 · Terminated
The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
- Z-0021-05 · Stryker Instruments, Instruments Div. · posted Oct 19, 2004 · Terminated
The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
- Z-0022-05 · Independence Technology LLC · posted Oct 19, 2004 · Terminated
Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
- Z-0019-05 · Health Directions, Inc · posted Oct 14, 2004 · Terminated
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device
- Z-0017-05 · Fresenius Medical Care North America · posted Oct 13, 2004 · Terminated
Peritoneal Dialysis Transfer Set may have occluded pathway
- Z-0018-05 · Datascope Corp · posted Oct 13, 2004 · Terminated
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
- Z-0014-05 · Zymed Laboratories Inc. · posted Oct 9, 2004 · Terminated
Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
- Z-0015-05 · Zymed Laboratories Inc. · posted Oct 9, 2004 · Terminated
Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
- Z-0016-05 · Abbott Laboratories, Inc · posted Oct 9, 2004 · Terminated
Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
- Z-0013-05 · Biomet, Inc. · posted Oct 8, 2004 · Terminated
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
- Z-0012-05 · General Electric Med Systems LLC · posted Oct 7, 2004 · Terminated
GE Healthcare received reports of intermittent low ejection fraction (EF) results for MUGA (multi-gated acquisitions) studies on Millennium VG systems. This issue can occasionally lead to distortions in the volume curve in some MUGA studies, and result in…
- Z-0001-05 · DeRoyal Wound Care · posted Oct 5, 2004 · Terminated
Wound dressing failed to meet sterility specifications.
- Z-0002-05 · ABX Diagnostics Inc · posted Oct 5, 2004 · Terminated
Device can generate overestimated platelet results.
- Z-0003-05 · ABX Diagnostics Inc · posted Oct 5, 2004 · Terminated
Device can generate overestimated platelet results.
- Z-0004-05 · Ameriwater Inc · posted Oct 5, 2004 · Terminated
The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
- Z-0005-05 · CooperSurgical, Inc. · posted Oct 5, 2004 · Terminated
Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System
- Z-0006-05 · Abbott Health Products, Inc. · posted Oct 5, 2004 · Terminated
Assay may give elevated patients results.
- Z-0007-05 · Dade Behring , Inc. · posted Oct 5, 2004 · Terminated
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
- Z-0008-05 · Ev3 · posted Oct 5, 2004 · Terminated
A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch…
- Z-0009-05 · Applied Medical Resources Corp · posted Oct 5, 2004 · Terminated
Inadequate trocar tip assembly that might yeild parts to patients.
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.