Medical device recalls: December 2004
The FDA posted 110 medical device recall records in December 2004, from 42 recall events by 35 companies. 110 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
- Baxter Healthcare Renal Div · 4 events, 4 records
- Baxter Healthcare Corp. · 2 events, 5 records
- Beckman Coulter Inc · 2 events, 2 records
- Roche Diagnostics Corp. · 2 events, 2 records
- Toshiba American Med Sys Inc · 2 events, 2 records
- AGA Medical Corporation · 1 event, 17 records
- Unomedical, Inc · 1 event, 16 records
- BD Diagnostic Systems · 1 event, 13 records
FDA root cause
- Other · 109
- Mixed-up of materials/components · 1
Not yet classified (110)
The FDA has posted these records but has not published a class for them yet.
- Z-0374-05 · Cincinnati Sub-Zero Products · posted Dec 30, 2004 · Terminated
Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
- Z-0375-05 · Proctor & Gamble Co · posted Dec 30, 2004 · Terminated
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
- Z-0376-05 · Proctor & Gamble Co · posted Dec 30, 2004 · Terminated
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
- Z-0377-05 · Proctor & Gamble Co · posted Dec 30, 2004 · Terminated
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
- Z-0378-05 · Proctor & Gamble Co · posted Dec 30, 2004 · Terminated
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
- Z-0392-05 · Baxter Healthcare Corp. · posted Dec 30, 2004 · Terminated
A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.
- Z-0371-05 · Beckman Coulter Inc · posted Dec 28, 2004 · Terminated
Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams…
- Z-0372-05 · Roche Diagnostics Corp. · posted Dec 28, 2004 · Terminated
A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
- Z-0373-05 · Dade Behring , Inc. · posted Dec 28, 2004 · Terminated
Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.
- Z-0350-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0351-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0352-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0353-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0354-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0355-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0356-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0357-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0358-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0359-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0360-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0361-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0362-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0363-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0364-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0365-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0366-05 · AGA Medical Corporation · posted Dec 24, 2004 · Terminated
Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
- Z-0367-05 · Baxter Healthcare Renal Div · posted Dec 24, 2004 · Terminated
Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
- Z-0368-05 · Cypress Medical Products, Ltd. · posted Dec 24, 2004 · Terminated
The elastic bandages which are labeled sterile have a lack of assurance of sterility.
- Z-0369-05 · Philips Medical Systems Sales & Service Region No. America · posted Dec 24, 2004 · Terminated
X-Ray system may fall downward and could possibly hit the patient.
- Z-0370-05 · Philips Medical Systems Sales & Service Region No. America · posted Dec 24, 2004 · Terminated
X-Ray system may fall downward and could possibly hit the patient.
- Z-0347-05 · Exactech, Inc. · posted Dec 23, 2004 · Terminated
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
- Z-0348-05 · Ocular Sciences, Inc. · posted Dec 23, 2004 · Terminated
Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.
- Z-0342-05 · Baxter Healthcare Corp. · posted Dec 22, 2004 · Terminated
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
- Z-0343-05 · Baxter Healthcare Corp. · posted Dec 22, 2004 · Terminated
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
- Z-0344-05 · Baxter Healthcare Corp. · posted Dec 22, 2004 · Terminated
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
- Z-0345-05 · Baxter Healthcare Corp. · posted Dec 22, 2004 · Terminated
A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
- Z-0346-05 · Hill-Rom, Inc. · posted Dec 22, 2004 · Terminated
Warning label containing instructions for proper electrical grounding was not attached.
- Z-0327-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0328-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0329-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0330-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0331-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0332-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0333-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0334-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0335-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0336-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0337-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0338-05 · Abbott Laboratories · posted Dec 21, 2004 · Terminated
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Z-0339-05 · Beckman Coulter Inc · posted Dec 21, 2004 · Terminated
Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
- Z-0340-05 · Weck · posted Dec 21, 2004 · Terminated
An incorrect electrosurgical cord was included in some of the packages.
- Z-0341-05 · Philips Medical Systems · posted Dec 21, 2004 · Terminated
In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
- Z-0324-05 · Diagnostic Products Corp · posted Dec 17, 2004 · Terminated
Low bias of 10 to 40% at different levels of insulin in samples.
- Z-0325-05 · Diamedix Corporation · posted Dec 17, 2004 · Terminated
Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
- Z-0326-05 · Medical Industries America Inc · posted Dec 17, 2004 · Terminated
Units could show an error code and stop functioning.
- Z-0311-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0312-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0313-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0314-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0315-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0316-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0317-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0318-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0319-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0320-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0321-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0322-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0323-05 · BD Diagnostic Systems · posted Dec 16, 2004 · Terminated
Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.
- Z-0306-05 · Edwards Lifesciences Research Medical Inc · posted Dec 15, 2004 · Terminated
Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
- Z-0307-05 · Precision Medical, Inc. · posted Dec 15, 2004 · Terminated
Battery charger can be overcharged and overheat
- Z-0308-05 · Precision Medical, Inc. · posted Dec 15, 2004 · Terminated
Battery charger can be overcharged and overheat
- Z-0309-05 · Ormco Corporation · posted Dec 15, 2004 · Terminated
Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
- Z-0310-05 · Medtronic Xomed, Inc. · posted Dec 15, 2004 · Terminated
The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient…
- Z-0304-05 · Smith & Nephew Inc · posted Dec 14, 2004 · Terminated
The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
- Z-0305-05 · Smith & Nephew Inc · posted Dec 14, 2004 · Terminated
The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
- Z-0300-05 · The Straumann Company · posted Dec 9, 2004 · Terminated
Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)
- Z-0301-05 · Baxter Healthcare Renal Div · posted Dec 9, 2004 · Terminated
Disconnection of the tubing at the clamp level of the UV Flash Transfer Set.
- Z-0302-05 · Boston Scientific Corp · posted Dec 9, 2004 · Terminated
The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
- Z-0303-05 · Boston Scientific Corp · posted Dec 9, 2004 · Terminated
The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
- Z-0274-05 · Pulmonetic Systems, Inc. · posted Dec 8, 2004 · Terminated
Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not…
- Z-0275-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0279-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0280-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0281-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0282-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0283-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0284-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0285-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0286-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0287-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0288-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0289-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0290-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0291-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0292-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0293-05 · Unomedical, Inc · posted Dec 8, 2004 · Terminated
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
- Z-0294-05 · Pulmonetic Systems, Inc. · posted Dec 8, 2004 · Terminated
Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not…
- Z-0295-05 · Pulmonetic Systems, Inc. · posted Dec 8, 2004 · Terminated
Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not…
- Z-0296-05 · Pulmonetic Systems, Inc. · posted Dec 8, 2004 · Terminated
Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not…
- Z-0297-05 · Roche Diagnostics Corp. · posted Dec 8, 2004 · Terminated
Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.
- Z-0298-05 · Cryolife Inc · posted Dec 8, 2004 · Terminated
CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD.
- Z-0299-05 · Baxter Healthcare Renal Div · posted Dec 8, 2004 · Terminated
The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.
- Z-0278-05 · Power Surgical Solutions · posted Dec 4, 2004 · Terminated
Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.
- Z-0276-05 · Chembio Diagnostic System Inc · posted Dec 3, 2004 · Terminated
Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of…
- Z-0277-05 · Chembio Diagnostic System Inc · posted Dec 3, 2004 · Terminated
Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of…
- Z-0270-05 · Toshiba American Med Sys Inc · posted Dec 2, 2004 · Terminated
Software defect causes images to be rotated 180 degrees.
- Z-0271-05 · B & K Medical Systems Inc. · posted Dec 2, 2004 · Terminated
Defect at probe tip may effect sterilization and electrical safety
- Z-0272-05 · Philips Medical Systems (Cleveland) Inc · posted Dec 2, 2004 · Terminated
There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
- Z-0273-05 · Toshiba American Med Sys Inc · posted Dec 2, 2004 · Terminated
Software defect causes patient identification number to be truncated.
- Z-0395-05 · Baxter Healthcare Renal Div · posted Dec 2, 2004 · Terminated
The air detector may not detect air bubbles consistently at the selected limit.
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.