Medical device recalls: December 2003
The FDA posted 66 medical device recall records in December 2003, from 41 recall events by 37 companies. 66 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, Inc · 2 events, 3 records
- Philips Medical Systems Sales & Service Region No. America · 2 events, 3 records
- Abbott Laboratories HPD/ADD/GPRD · 2 events, 2 records
- Cardinal Health · 2 events, 2 records
- Ethicon Endo-Surgery · 1 event, 15 records
- Respironics, Inc. · 1 event, 3 records
- The OR Group · 1 event, 3 records
- 3m Health Care · 1 event, 2 records
FDA root cause
- Other · 49
- Nonconforming Material/Component · 17
Not yet classified (66)
The FDA has posted these records but has not published a class for them yet.
- Z-0273-04 · Remel, Inc. · posted Dec 25, 2003 · Terminated
Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
- Z-0274-04 · Abbott Laboratories, Inc · posted Dec 25, 2003 · Terminated
Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
- Z-0275-04 · Hypoguard USA, Inc. · posted Dec 25, 2003 · Terminated
When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- Z-0276-04 · Hypoguard USA, Inc. · posted Dec 25, 2003 · Terminated
When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- Z-0262-04 · Abbott Laboratories, Inc · posted Dec 24, 2003 · Terminated
Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
- Z-0263-04 · Abbott Laboratories, Inc · posted Dec 24, 2003 · Terminated
Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
- Z-0264-04 · Bausch & Lomb Inc · posted Dec 24, 2003 · Terminated
The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
- Z-0265-04 · Medtronic MiniMed · posted Dec 24, 2003 · Terminated
Accessory software fails to report certain reports following download of data from 712 pump.
- Z-0266-04 · Cardinal Health · posted Dec 24, 2003 · Terminated
The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
- Z-0267-04 · Stryker Medical · posted Dec 24, 2003 · Terminated
The user may be pinched by the siderail when raising or lowering the siderail.
- Z-0268-04 · Philips Medical Systems Sales & Service Region No. America · posted Dec 24, 2003 · Terminated
Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.
- Z-0270-04 · Philips Medical Systems Sales & Service Region No. America · posted Dec 24, 2003 · Terminated
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
- Z-0271-04 · Philips Medical Systems Sales & Service Region No. America · posted Dec 24, 2003 · Terminated
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
- Z-0272-04 · Edwards Lifesciences Corporation of Puerto Rico · posted Dec 24, 2003 · Terminated
Lot is being recalled because some of the kits contain an incorrect guidewire.
- Z-0252-04 · Power Medical Interventions · posted Dec 19, 2003 · Terminated
improper staple formation or anvil jam
- Z-0253-04 · Power Medical Interventions · posted Dec 19, 2003 · Terminated
improper staple formation or anvil jam
- Z-0729-03 · Health Care Manufacturing Inc · posted Dec 19, 2003 · Terminated
Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels
- Z-0235-04 · Misys Healthcare Systems · posted Dec 18, 2003 · Terminated
Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
- Z-0236-04 · 3m Health Care · posted Dec 18, 2003 · Terminated
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to…
- Z-0237-04 · 3m Health Care · posted Dec 18, 2003 · Terminated
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to…
- Z-0239-04 · Drug Free Enterprises Inc · posted Dec 18, 2003 · Terminated
Lacks professional use labeling and firm name and address.
- Z-0240-04 · Abbott Laboratories Diagnostic Div · posted Dec 18, 2003 · Terminated
False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
- Z-0241-04 · Fisher & Paykel Healthcare Inc · posted Dec 18, 2003 · Terminated
Component placement presents risk of electrocution to patients.
- Z-0242-04 · Edwards Lifesciences AG · posted Dec 18, 2003 · Terminated
Seal integrity, sterility not assured.
- Z-0243-04 · Cardinal Health · posted Dec 18, 2003 · Terminated
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
- Z-0244-04 · Welch Allyn Inc · posted Dec 18, 2003 · Terminated
Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
- Z-0246-04 · Q-Med Corporation · posted Dec 18, 2003 · Terminated
This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
- Z-0247-04 · Smith And Nephew, Inc. Endoscopy Division · posted Dec 18, 2003 · Terminated
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- Z-0248-04 · Smith And Nephew, Inc. Endoscopy Division · posted Dec 18, 2003 · Terminated
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- Z-0250-04 · General Electric Medical Systems Information Technology · posted Dec 18, 2003 · Terminated
Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
- Z-0251-04 · Owens & Minor Distribution, Inc. · posted Dec 18, 2003 · Terminated
Counterfeit product is an unapproved medical device with associated potential health hazard.
- Z-0212-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0213-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0214-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0215-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0216-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0217-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0218-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0219-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0220-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0221-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0222-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0223-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0224-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0225-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0226-04 · Ethicon Endo-Surgery · posted Dec 17, 2003 · Terminated
A defective articulation band may result in improper staple formation with possible hematosis.
- Z-0227-04 · Boehringer Laboratories Inc · posted Dec 17, 2003 · Terminated
Inadequate bond where the tube attaches to the inlet of the bulb.
- Z-0228-04 · LightMed USA Inc · posted Dec 17, 2003 · Terminated
Firm needed to include calibration procedures in user guide.
- Z-0229-04 · Alcon Laboratories, Inc · posted Dec 17, 2003 · Terminated
The firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had…
- Z-0230-04 · Abbott Laboratories HPD/ADD/GPRD · posted Dec 17, 2003 · Terminated
Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
- Z-0231-04 · Medtronic Surgical Navigation Tech, Inc · posted Dec 17, 2003 · Terminated
Surgical devices intended for single use were not labeled for single use.
- Z-0233-04 · Kendall Healthcare Products Co · posted Dec 17, 2003 · Terminated
Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm
- Z-0234-04 · Kendall Healthcare Products Co · posted Dec 17, 2003 · Terminated
Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm
- Z-0207-04 · AGFA Corp. · posted Dec 11, 2003 · Terminated
The GS1 circuit board may fail resulting in smoke or fire.
- Z-0209-04 · Abbott Laboratories HPD/ADD/GPRD · posted Dec 11, 2003 · Terminated
Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
- Z-0211-04 · Interpore Cross International Inc · posted Dec 11, 2003 · Terminated
Step drills from Lot 25947 may have been mis-etched.
- Z-0178-04 · Respironics, Inc. · posted Dec 10, 2003 · Terminated
product does not contain built in exhalation port
- Z-0179-04 · Respironics, Inc. · posted Dec 10, 2003 · Terminated
product does not contain built in exhalation port
- Z-0180-04 · Respironics, Inc. · posted Dec 10, 2003 · Terminated
product does not contain built in exhalation port
- Z-0182-04 · The OR Group · posted Dec 10, 2003 · Terminated
Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb
- Z-0183-04 · The OR Group · posted Dec 10, 2003 · Terminated
Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb
- Z-0184-04 · The OR Group · posted Dec 10, 2003 · Terminated
Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb
- Z-0206-04 · Hill-Rom, Inc. · posted Dec 10, 2003 · Terminated
The ambulatory assist bar may not lock into position and may come out of place due to incorrect assembly.
- Z-0177-04 · Baxter Healthcare Corp. · posted Dec 4, 2003 · Terminated
Use of the dialyzers may cause iritis (red-eye) patient reactions.
- Z-0175-03 · Siemens Medical Solutions USA, Inc · posted Dec 3, 2003 · Terminated
Equipment SAR monitor does not accept new patient data, incorrect RF levels may be administered to the patient.
- Z-0176-03 · Varian Brachytherary Virginia · posted Dec 3, 2003 · Terminated
The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
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.