Medical device recalls: March 2005
The FDA posted 103 medical device recall records in March 2005, from 50 recall events by 40 companies. 103 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
- Diasorin Inc. · 8 events, 8 records
- Roche Diagnostics Corp. · 3 events, 12 records
- Becton Dickinson Infusion Therapy · 2 events, 8 records
- Medtronic Inc. Cardiac Rhythm Managment · 1 event, 8 records
- Proctor & Gamble Co · 1 event, 8 records
- Cypress Medical Products, Ltd. · 1 event, 5 records
- Hospira Inc. · 1 event, 5 records
- Ethicon Endo-Surgery · 1 event, 4 records
FDA root cause
- Other · 99
- Process control · 2
- Nonconforming Material/Component · 1
- Device Design · 1
Not yet classified (103)
The FDA has posted these records but has not published a class for them yet.
- Z-0666-05 · Terumo Cardiovascular Systems Corp · posted Mar 31, 2005 · Terminated
The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
- Z-0667-05 · Terumo Cardiovascular Systems Corp · posted Mar 31, 2005 · Terminated
The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.
- Z-0661-05 · Hill-Rom, Inc. · posted Mar 30, 2005 · Terminated
Siderails may stay up without latching into place.
- Z-0662-05 · Nellcor Puritan Bennett · posted Mar 30, 2005 · Terminated
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Z-0663-05 · Nellcor Puritan Bennett · posted Mar 30, 2005 · Terminated
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Z-0664-05 · Nellcor Puritan Bennett · posted Mar 30, 2005 · Terminated
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Z-0665-05 · Nellcor Puritan Bennett · posted Mar 30, 2005 · Terminated
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Z-0658-05 · Diasorin Inc. · posted Mar 29, 2005 · Terminated
The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.
- Z-0659-05 · Bio Rad Laboratories, Inc. · posted Mar 29, 2005 · Terminated
New instructions to recommend against using samples with visibly high level of blood.
- Z-0660-05 · Abbott Health Products, Inc. · posted Mar 29, 2005 · Terminated
Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
- Z-0654-05 · Ethicon Endo-Surgery · posted Mar 25, 2005 · Terminated
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Z-0655-05 · Ethicon Endo-Surgery · posted Mar 25, 2005 · Terminated
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Z-0656-05 · Ethicon Endo-Surgery · posted Mar 25, 2005 · Terminated
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Z-0657-05 · Ethicon Endo-Surgery · posted Mar 25, 2005 · Terminated
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
- Z-0652-05 · Compumedics Usa, Ltd · posted Mar 24, 2005 · Terminated
Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
- Z-0653-05 · Compumedics Usa, Ltd · posted Mar 24, 2005 · Terminated
Under specific conditions, the housing of the pulse oximeter contected to the amplifier can become excessively warm causing a burn upon contact with skin.
- Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch ↗Z-0027-05 · Bioteque America Inc · posted Mar 23, 2005 · Terminated
product is marketed without a 510(k)
- Z-0641-05 · Heartsine Technologies Inc · posted Mar 23, 2005 · Terminated
The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a…
- Z-0647-05 · Teleflex Medical, Inc. · posted Mar 23, 2005 · Terminated
Firm received complaints of leaking urine collection bags.
- Z-0648-05 · Teleflex Medical, Inc. · posted Mar 23, 2005 · Terminated
Firm received complaints of leaking urine collection bags.
- Z-0649-05 · Roche Diagnostics Corp. · posted Mar 23, 2005 · Terminated
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Z-0650-05 · Roche Diagnostics Corp. · posted Mar 23, 2005 · Terminated
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Z-0651-05 · Roche Diagnostics Corp. · posted Mar 23, 2005 · Terminated
The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Z-0642-05 · Cypress Medical Products, Ltd. · posted Mar 22, 2005 · Terminated
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
- Z-0643-05 · Cypress Medical Products, Ltd. · posted Mar 22, 2005 · Terminated
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
- Z-0644-05 · Cypress Medical Products, Ltd. · posted Mar 22, 2005 · Terminated
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
- Z-0645-05 · Cypress Medical Products, Ltd. · posted Mar 22, 2005 · Terminated
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
- Z-0646-05 · Cypress Medical Products, Ltd. · posted Mar 22, 2005 · Terminated
The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
- Z-0628-05 · Becton Dickinson Infusion Therapy · posted Mar 18, 2005 · Terminated
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Z-0629-05 · Becton Dickinson Infusion Therapy · posted Mar 18, 2005 · Terminated
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Z-0630-05 · Becton Dickinson Infusion Therapy · posted Mar 18, 2005 · Terminated
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Z-0631-05 · Becton Dickinson Infusion Therapy · posted Mar 18, 2005 · Terminated
Various procedure trays and kits may have an insufficient seal, thus compromising sterility.
- Z-0632-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
- Z-0633-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.
- Z-0634-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
- Z-0635-05 · Millar Instruments, Inc · posted Mar 18, 2005 · Terminated
Wire braiding protruding from the catheter.
- Z-0636-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing…
- Z-0637-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
- Z-0638-05 · Diasorin Inc. · posted Mar 18, 2005 · Terminated
An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be…
- Z-0639-05 · Boston Scientific · posted Mar 18, 2005 · Terminated
The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.
- Z-0640-05 · Philips Medical Systems Sales & Service Region No. America · posted Mar 18, 2005 · Terminated
Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
- Z-0617-05 · Hospira Inc. · posted Mar 15, 2005 · Terminated
Syringes could possibly allow air to enter the patient's vascular system.
- Z-0618-05 · Hospira Inc. · posted Mar 15, 2005 · Terminated
Syringes could possibly allow air to enter the patient's vascular system.
- Z-0619-05 · Hospira Inc. · posted Mar 15, 2005 · Terminated
Syringes could possibly allow air to enter the patient's vascular system.
- Z-0620-05 · Hospira Inc. · posted Mar 15, 2005 · Terminated
Syringes could possibly allow air to enter the patient's vascular system.
- Z-0621-05 · Hospira Inc. · posted Mar 15, 2005 · Terminated
Syringes could possibly allow air to enter the patient's vascular system.
- Z-0622-05 · Integra Neuro Sciences · posted Mar 15, 2005 · Terminated
LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
- Z-0623-05 · Integra Neuro Sciences · posted Mar 15, 2005 · Terminated
LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
- Z-0624-05 · Heraeus Kulzer Inc. · posted Mar 15, 2005 · Terminated
Packaging defects could result in improper mixing ratios and unusable impressions.
- Z-0625-05 · Heraeus Kulzer Inc. · posted Mar 15, 2005 · Terminated
Packaging defects could result in improper mixing ratios and unusable impressions.
- Z-0626-05 · Heraeus Kulzer Inc. · posted Mar 15, 2005 · Terminated
Packaging defects could result in improper mixing ratios and unusable impressions.
- Z-0627-05 · Heraeus Kulzer Inc. · posted Mar 15, 2005 · Terminated
Packaging defects could result in improper mixing ratios and unusable impressions.
- Z-0615-05 · Medtronic Neurosurgery · posted Mar 12, 2005 · Terminated
Products are mislabeled.
- Z-0616-05 · Medtronic Neurosurgery · posted Mar 12, 2005 · Terminated
Products are mislabeled.
- Z-0554-05 · Medline Industries, Inc. · posted Mar 11, 2005 · Terminated
There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.
- Z-0589-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0590-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0591-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0592-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0593-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0594-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0595-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0596-05 · Proctor & Gamble Co · posted Mar 11, 2005 · Terminated
The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
- Z-0597-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0598-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0599-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0600-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0601-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0602-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0603-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0604-05 · Medtronic Inc. Cardiac Rhythm Managment · posted Mar 11, 2005 · Terminated
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a…
- Z-0605-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0606-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0607-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0608-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0609-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0610-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0611-05 · Roche Diagnostics Corp. · posted Mar 11, 2005 · Terminated
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
- Z-0562-05 · Medtronic Emergency Response Systems, Inc. · posted Mar 10, 2005 · Terminated
Potential to not detect patients at the low end of the patient impedance range.
- Z-0580-05 · Cryolife Inc · posted Mar 10, 2005 · Terminated
Records noted that the infant donor's mother had tested positive for Hepatitis B.
- Z-0581-05 · Cryolife Inc · posted Mar 10, 2005 · Terminated
Records noted that the infant donor's mother had tested positive for Hepatitis B.
- Z-0582-05 · Teleflex Medical · posted Mar 10, 2005 · Terminated
Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
- Z-0583-05 · Kinetic Concepts, Inc · posted Mar 10, 2005 · Terminated
Weld failure causes side rail welds to turn upside down or break off of the bed.
- Z-0584-05 · Becton Dickinson Infusion Therapy · posted Mar 10, 2005 · Terminated
The Y-luer connection may crack during normal product use.
- Z-0585-05 · Becton Dickinson Infusion Therapy · posted Mar 10, 2005 · Terminated
The Y-luer connection may crack during normal product use.
- Z-0586-05 · Becton Dickinson Infusion Therapy · posted Mar 10, 2005 · Terminated
The Y-luer connection may crack during normal product use.
- Z-0587-05 · Becton Dickinson Infusion Therapy · posted Mar 10, 2005 · Terminated
The Y-luer connection may crack during normal product use.
- Z-0588-05 · Cordis Corporation · posted Mar 10, 2005 · Terminated
The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
- Z-0577-05 · DeRoyal Technologies Inc · posted Mar 9, 2005 · Terminated
There is a possibility of water leaking from the welded seam of the blanket.
- Z-0578-05 · Sybaritic, Inc · posted Mar 9, 2005 · Terminated
Device is performing functions that are not cleared in the 510(k).
- Z-0579-05 · Dentsply Friadent Ceramed · posted Mar 9, 2005 · Terminated
PepGen P-15 Putty kit was labeled with the incorrect expiration date.
- Z-0570-05 · Ross Products Division Abbott Laboratories · posted Mar 8, 2005 · Terminated
Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.
- Z-0571-05 · Maquet Inc · posted Mar 8, 2005 · Terminated
Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.
- Z-0572-05 · Diasorin Inc. · posted Mar 8, 2005 · Terminated
Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.
- Z-0573-05 · Roche Diagnostics Corp. · posted Mar 8, 2005 · Terminated
The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
- Z-0574-05 · Roche Diagnostics Corp. · posted Mar 8, 2005 · Terminated
The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
- Z-0575-05 · Deals Nothing Over A Dollar · posted Mar 8, 2005 · Terminated
A defective seal allows water into the handle of the toothbrush via the bristles, and rusty water seeps back out of the toothbrush around the bristles.
- Z-0576-05 · Beckman Coulter Inc · posted Mar 8, 2005 · Terminated
Variability in results on Patient and QC results of 20-25%, high and low.
- Z-0568-05 · Alaris Medical Systems Inc · posted Mar 3, 2005 · Terminated
The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from…
- Z-0569-05 · Becton Dickinson & Company · posted Mar 3, 2005 · Terminated
Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
- Z-0545-05 · IV Flush LLC · posted Mar 1, 2005 · Terminated
Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
- Z-0546-05 · IV Flush LLC · posted Mar 1, 2005 · Terminated
Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.
- Z-0567-05 · Greer Laboratories Inc · posted Mar 1, 2005 · Terminated
Product may not be sterile.
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.