Medical device recalls: January 2007
The FDA posted 84 medical device recall records in January 2007, from 53 recall events by 47 companies. 84 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
- Arjo, Inc. · 3 events, 3 records
- Stryker Howmedica Osteonics Corp. · 2 events, 6 records
- Drew Scientific Group PLC · 2 events, 4 records
- MAQUET Inc. · 2 events, 2 records
- Smiths Medical ASD, Inc. · 2 events, 2 records
- Depuy Orthopaedics, Inc. · 1 event, 10 records
- Philips Medical Systems North America Co. Phillips · 1 event, 6 records
- Bayer Healthcare, LLC (Diagnostics Division) · 1 event, 3 records
FDA root cause
- Other · 80
- Software design · 3
- Process control · 1
Not yet classified (84)
The FDA has posted these records but has not published a class for them yet.
- Z-0359-2007 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Jan 30, 2007 · Completed
PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- Z-0360-2007 · Davol, Inc., Sub. C. R. Bard, Inc. · posted Jan 30, 2007 · Completed
PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- Z-0340-2007 · Medtronic Perfusion Systems · posted Jan 25, 2007 · Terminated
An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
- Z-0341-2007 · Cyberonics, Inc · posted Jan 25, 2007 · Terminated
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
- Z-0342-2007 · Cyberonics, Inc · posted Jan 25, 2007 · Terminated
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
- Z-0350-2007 · MAQUET Inc. · posted Jan 25, 2007 · Terminated
The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.
- Z-0363-2007 · Bock,Otto,Orthopedic Ind,Inc · posted Jan 25, 2007 · Terminated
A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong…
- Z-0365-2007 · Terang Nusa Sdn Bhd · posted Jan 25, 2007 · Terminated
Some of the packages labeled as latex-free actually contain latex gloves.
- Z-0366-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0367-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0368-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0369-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0370-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0371-2007 · Philips Medical Systems North America Co. Phillips · posted Jan 25, 2007 · Terminated
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
- Z-0372-2007 · MAQUET Inc. · posted Jan 25, 2007 · Terminated
Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not…
- Z-0373-2007 · GE Healthcare Integrated IT Solutions · posted Jan 25, 2007 · Terminated
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
- Z-0376-2007 · Bio-Rad Laboratories Inc · posted Jan 25, 2007 · Terminated
The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
- Z-0377-2007 · Cook Urological, Inc. · posted Jan 25, 2007 · Terminated
Lack of assurance of sterility, as the packages may not have been sealed.
- Z-0378-2007 · Smiths Medical ASD, Inc. · posted Jan 25, 2007 · Terminated
The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
- Z-0361-2007 · Diagnostic Chemicals, Ltd. · posted Jan 23, 2007 · Terminated
Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end…
- Z-0362-2007 · Suros Surgical Systems Inc. · posted Jan 23, 2007 · Terminated
The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
- Z-0364-2007 · Abbott Point of Care Inc. · posted Jan 23, 2007 · Terminated
Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
- Z-0343-2007 · MRL, Inc., A Welch Allyn Company · posted Jan 19, 2007 · Terminated
Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.
- Z-0349-2007 · OrthoHelix Surgical Designs Inc · posted Jan 19, 2007 · Terminated
The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
- Z-0357-2007 · Continental Medical Labs,Inc · posted Jan 18, 2007 · Terminated
Fibrin Analysis Catheter Testying System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.
- Z-0358-2007 · I-Flow Corporation · posted Jan 18, 2007 · Terminated
The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
- Z-0351-2007 · Bayer Healthcare, LLC (Diagnostics Division) · posted Jan 17, 2007 · Terminated
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.
- Z-0352-2007 · Bayer Healthcare, LLC (Diagnostics Division) · posted Jan 17, 2007 · Terminated
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.…
- Z-0353-2007 · Bayer Healthcare, LLC (Diagnostics Division) · posted Jan 17, 2007 · Terminated
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.…
- Z-0354-2007 · Abbott Spine · posted Jan 17, 2007 · Terminated
Tip of devices may dislodge while in use during surgery.
- Z-0355-2007 · Abbott Spine · posted Jan 17, 2007 · Terminated
Tip of devices may dislodge while in use during surgery.
- Z-0356-2007 · Roche Diagnostics Corp. · posted Jan 17, 2007 · Terminated
Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant…
- Z-0455-2007 · Embeem Inc. · posted Jan 17, 2007 · Terminated
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
- Z-0470-2007 · International Technidyne Corp. · posted Jan 13, 2007 · Terminated
Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send or PRINT RESULTS feature.
- Z-0472-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 13, 2007 · Terminated
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Z-0473-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 13, 2007 · Terminated
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Z-0474-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 13, 2007 · Terminated
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Z-0475-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 13, 2007 · Terminated
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Z-0476-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 13, 2007 · Terminated
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
- Z-0456-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0457-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0458-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0459-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0460-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0461-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0462-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0463-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0464-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0465-2007 · Depuy Orthopaedics, Inc. · posted Jan 11, 2007 · Terminated
Chamfer Step Defect-The surgeon may have difficulty in assembling /seating the polyethylene insert into the tray due to a Chamfer step defect.
- Z-0478-2007 · Arjo, Inc. · posted Jan 11, 2007 · Terminated
The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.
- Z-0479-2007 · Arjo, Inc. · posted Jan 11, 2007 · Terminated
The Kwiktrak Gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.
- Z-0480-2007 · Viasys Respiratory Care, Inc. · posted Jan 11, 2007 · Terminated
The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
- Z-0481-2007 · Viasys Respiratory Care, Inc. · posted Jan 11, 2007 · Terminated
The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
- Z-0482-2007 · Arjo, Inc. · posted Jan 11, 2007 · Terminated
The carabineer may not be correctly attached to the reacher and the portable patient lift may drop.
- Z-0483-2007 · Baxter Healthcare Corp. · posted Jan 11, 2007 · Terminated
Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to…
- Z-0484-2007 · Baxter Healthcare Corp. · posted Jan 11, 2007 · Terminated
Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to…
- Z-0485-2007 · Fisher & Paykel Healthcare Ltd · posted Jan 11, 2007 · Terminated
This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent…
- GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA ↗Z-0486-2007 · Varian Medical Systems · posted Jan 11, 2007 · Terminated
Medical device for patient treatment does not meet electrical safety standards.
- Z-0487-2007 · Varian Medical Systems · posted Jan 11, 2007 · Terminated
Medical device for patient treatment does not meet electrical safety standards.
- Z-0488-2007 · Abbott Laboratories MPG · posted Jan 11, 2007 · Terminated
The lots of ARCHITECT LH Reagent List 6C25-22, have the potential to generate patient specimen results that are elevated. Correlation studies have demonstrated an upward shift in slope for patient results of approximately 13% on average when compared to…
- Z-0489-2007 · Synthes · posted Jan 11, 2007 · Terminated
Hole is malformed, leading to reduced construct strength.
- Z-0299-2007 · Advanced Bionics Corporation · posted Jan 10, 2007 · Terminated
A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.
- Z-0445-2007 · Southern Prosthetic Supply Co. · posted Jan 10, 2007 · Terminated
Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail
- Z-0446-2007 · Respironics, Inc. · posted Jan 10, 2007 · Terminated
AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
- Z-0447-2007 · Respironics, Inc. · posted Jan 10, 2007 · Terminated
AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
- Z-0467-2007 · Stryker Howmedica Osteonics Corp. · posted Jan 10, 2007 · Terminated
The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.
- Z-0468-2007 · Ossur · posted Jan 10, 2007 · Terminated
Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot
- Z-0292-2007 · Terumo Cardiovascular Systems Corp · posted Jan 9, 2007 · Terminated
Six inch roller pumps were mislabeled as 4 inch roller pumps.
- Z-0293-2007 · Terumo Cardiovascular Systems Corp · posted Jan 9, 2007 · Terminated
An incorrect serial number was placed on one roller pump.
- Z-0444-2007 · Puritan Bennett Corporation · posted Jan 9, 2007 · Terminated
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
- Z-0448-2007 · Drew Scientific Group PLC · posted Jan 9, 2007 · Terminated
Flags and alerts on the user interface will not automatically transfering to the LIS.
- Z-0449-2007 · Drew Scientific Group PLC · posted Jan 9, 2007 · Terminated
Flags and alerts on the user interface will not automatically transfering to the LIS.
- Z-0454-2007 · Abbott Laboratories Inc. · posted Jan 9, 2007 · Terminated
Erratic elevated results and or the inability to calibrate due to imprecision.
- Z-0466-2007 · Integra LifeSciences Corp. · posted Jan 9, 2007 · Terminated
Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
- Z-0471-2007 · Beckman Coulter Inc · posted Jan 9, 2007 · Terminated
The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter.
- Z-0206-2007 · Discount Diabetic Supply · posted Jan 5, 2007 · Terminated
Counterfeit-blood glucose test strips (manufacturer unknown)
- Z-0266-2007 · Core Care Technologies, Inc · posted Jan 5, 2007 · Terminated
Counterfeit product (manufacturer unknown)
- Z-0338-2007 · Edwards Lifesciences Technology SARL · posted Jan 5, 2007 · Terminated
Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does…
- Z-0339-2007 · Smiths Medical ASD, Inc. · posted Jan 5, 2007 · Terminated
Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
- Z-0450-2007 · Drew Scientific Group PLC · posted Jan 5, 2007 · Terminated
System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
- Z-0451-2007 · Drew Scientific Group PLC · posted Jan 5, 2007 · Terminated
System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
- Z-0452-2007 · Lifescan Inc · posted Jan 5, 2007 · Terminated
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
- Z-0453-2007 · Lifescan Inc · posted Jan 5, 2007 · Terminated
Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
- Z-0469-2007 · Mizuho USA, Inc. · posted Jan 5, 2007 · Terminated
False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
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.