Medical device recalls: January 2005
The FDA posted 75 medical device recall records in January 2005, from 41 recall events by 33 companies. 75 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 Corp. · 3 events, 4 records
- Harry J Bosworth Company · 3 events, 3 records
- Cordis Corporation · 2 events, 2 records
- Nellcor Puritan Bennett Inc · 2 events, 2 records
- Stryker Endoscopy · 2 events, 2 records
- Weck · 2 events, 2 records
- Bio-Med Devices, Inc. · 1 event, 8 records
- Boston Scientific Corporation · 1 event, 8 records
FDA root cause
- Other · 71
- Nonconforming Material/Component · 3
- Device Design · 1
Not yet classified (75)
The FDA has posted these records but has not published a class for them yet.
- Z-0423-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0424-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0425-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0426-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0427-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0428-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0429-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0430-05 · Bio-Med Devices, Inc. · posted Jan 29, 2005 · Terminated
Adapters may be occluded potentially preventing inhalation
- Z-0442-05 · Smiths Medical MD, Inc. · posted Jan 28, 2005 · Terminated
The catheter became disconnected from the port while implanted in the patient.
- Z-0443-05 · Baxter Healthcare Corp. · posted Jan 28, 2005 · Terminated
The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
- Z-0444-05 · Nellcor Puritan Bennett Inc · posted Jan 28, 2005 · Terminated
Wires on battery may loosen causing disconnection.
- Z-0445-05 · Nellcor Puritan Bennett Inc · posted Jan 28, 2005 · Terminated
Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
- Z-0446-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Z-0447-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Z-0448-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads iof the bone screws included in the kit.
- Z-0449-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Z-0450-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Z-0451-05 · Warsaw Orthopedic, Inc. · posted Jan 28, 2005 · Terminated
The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
- Z-0452-05 · International Chemical Inc. · posted Jan 28, 2005 · Terminated
Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
- Z-0453-05 · International Chemical Inc. · posted Jan 28, 2005 · Terminated
Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.
- Z-0454-05 · Boston Scientific Scimed · posted Jan 28, 2005 · Terminated
The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent…
- Z-0411-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0412-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0413-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0414-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0415-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0416-05 · S S C O R Inc · posted Jan 27, 2005 · Terminated
Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
- Z-0417-05 · Stryker Endoscopy · posted Jan 27, 2005 · Terminated
A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.
- Z-0438-05 · Hospira Inc · posted Jan 27, 2005 · Terminated
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
- Z-0439-05 · Hospira Inc · posted Jan 27, 2005 · Terminated
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
- Z-0440-05 · Ethicon Endo-Surgery · posted Jan 27, 2005 · Terminated
A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.
- Z-0441-05 · Power Surgical Solutions · posted Jan 27, 2005 · Terminated
Device is missing the sub-collet component within the dissecting tool package.
- Z-0431-05 · Harvard Clinical Technology · posted Jan 26, 2005 · Terminated
Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- Z-0432-05 · Harvard Clinical Technology · posted Jan 26, 2005 · Terminated
Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- Z-0433-05 · Harvard Clinical Technology · posted Jan 26, 2005 · Terminated
Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.Z-0434-05 · Cordis Corporation · posted Jan 26, 2005 · Terminated
Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the…
- Z-0435-05 · Abbott Laboratories, Inc · posted Jan 26, 2005 · Terminated
Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.
- Z-0436-05 · Medivance Inc. · posted Jan 26, 2005 · Terminated
Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
- Z-0437-05 · Cordis Corporation · posted Jan 26, 2005 · Terminated
Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
- Z-0418-05 · Weck · posted Jan 25, 2005 · Terminated
Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
- Z-0419-05 · Harry J Bosworth Company · posted Jan 25, 2005 · Terminated
The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up.
- Z-0420-05 · Harry J Bosworth Company · posted Jan 25, 2005 · Terminated
The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
- Z-0421-05 · Harry J Bosworth Company · posted Jan 25, 2005 · Terminated
The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
- Z-0422-05 · Spacelabs Medical Incorporated · posted Jan 25, 2005 · Terminated
Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
- Z-0403-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0404-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0405-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0406-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0407-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0408-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0409-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0410-05 · Boston Scientific Corporation · posted Jan 20, 2005 · Terminated
Catheter separation immediately distal to the nose of the suture wing.
- Z-0396-05 · Advanced Bionics Corporation · posted Jan 15, 2005 · Terminated
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
- Z-0397-05 · Baxter Healthcare Renal Div · posted Jan 15, 2005 · Terminated
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
- Z-0398-05 · Cardiac Science, Inc. · posted Jan 15, 2005 · Terminated
AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that…
- Z-0399-05 · Cardiac Science, Inc. · posted Jan 15, 2005 · Terminated
AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that…
- Z-0400-05 · Cardiac Science, Inc. · posted Jan 15, 2005 · Terminated
AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that…
- Z-0401-05 · Stryker Endoscopy · posted Jan 15, 2005 · Terminated
The label on the outside of the shipping box has an incorrect description of the screw diameter.
- Z-0402-05 · Hill-Rom, Inc. · posted Jan 15, 2005 · Terminated
A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame.
- Z-0391-05 · Medtronic Inc, Neurological & Spinal Division · posted Jan 13, 2005 · Terminated
Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen…
- Z-0393-05 · Weck · posted Jan 13, 2005 · Terminated
The flush port on some appliers was occluded with an epoxy resin during manufacturing.
- Z-0394-05 · Baxter Healthcare Corp. · posted Jan 13, 2005 · Terminated
Logix-CM software version 3.0.4 has not completed its official release process.
- Z-0388-05 · Zimmer Orthopaedic Surgical Products · posted Jan 12, 2005 · Terminated
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
- Z-0389-05 · Zimmer Orthopaedic Surgical Products · posted Jan 12, 2005 · Terminated
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
- Z-0390-05 · Zimmer Orthopaedic Surgical Products · posted Jan 12, 2005 · Terminated
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
- Z-0349-05 · Arrow International Inc · posted Jan 8, 2005 · Terminated
complaints of vessel erosion when using this product
- Z-0385-05 · Baxter Healthcare Corp. · posted Jan 8, 2005 · Terminated
A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
- Z-0386-05 · Baxter Healthcare Corp. · posted Jan 8, 2005 · Terminated
A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
- Z-0387-05 · Ortho-Clinical Diagnostics · posted Jan 8, 2005 · Terminated
Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
- Z-0383-05 · Roche Diagnostics Corp. · posted Jan 6, 2005 · Terminated
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
- Z-0384-05 · Hydro Med Products, Inc · posted Jan 6, 2005 · Terminated
Defective packaging, potential for breech in sterility.
- Z-0379-05 · Fischer Imaging Corporation · posted Jan 5, 2005 · Terminated
X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
- Z-0380-05 · Pride Mobility Product Corp · posted Jan 5, 2005 · Terminated
intermittent operation
- Z-0381-05 · Pride Mobility Product Corp · posted Jan 5, 2005 · Terminated
intermittent operation
- Z-0382-05 · Omron Healthcare, Inc. · posted Jan 5, 2005 · Terminated
A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
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.