Medical device recalls: December 2008
The FDA posted 114 medical device recall records in December 2008, from 55 recall events by 45 companies. 114 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
- Terumo Cardiovascular Systems Corporation · 4 events, 9 records
- GE Healthcare Integrated IT Solutions · 3 events, 3 records
- Siemens Medical Solutions USA, Inc · 2 events, 7 records
- FHC, Inc. · 2 events, 4 records
- OraSure Technologies, Inc. · 2 events, 4 records
- Arjo, Inc. · 2 events, 3 records
- Boston Scientific Corporation · 2 events, 2 records
- C R Bard Inc · 1 event, 23 records
FDA root cause
- Component design/selection · 31
- Nonconforming Material/Component · 16
- Software design · 14
- Process control · 14
- Equipment maintenance · 11
- Other · 5
- Mixed-up of materials/components · 5
- Pending · 4
Not yet classified (114)
The FDA has posted these records but has not published a class for them yet.
- Z-0472-2009 · GE Healthcare Integrated IT Solutions · posted Dec 31, 2008 · Terminated
Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.
- Z-0507-2009 · Alphatec Spine, Inc. · posted Dec 31, 2008 · Terminated
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot…
- Z-0508-2009 · Alphatec Spine, Inc. · posted Dec 31, 2008 · Terminated
Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot…
- Z-0522-2009 · Philips Medical Systems · posted Dec 31, 2008 · Terminated
The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
- Z-0523-2009 · Philips Medical Systems · posted Dec 31, 2008 · Terminated
The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.
- Z-0604-2009 · Cordis Corporation · posted Dec 30, 2008 · Terminated
Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.
- Z-0610-2009 · Stryker Leibinger USA · posted Dec 30, 2008 · Terminated
A template is supposed to accompany the product, but it was not included with this lot.
- Z-0617-2009 · Sunrise Medical · posted Dec 30, 2008 · Terminated
potential for sieve beds to have been incorrectly assembled
- Z-0618-2009 · ConvaTec · posted Dec 30, 2008 · Terminated
It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.
- Z-0445-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 29, 2008 · Terminated
The power supply may fail to charge the batteries due to various hardware malfunctions.
- Z-0446-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 29, 2008 · Terminated
The power supply may fail to charge the batteries due to various hardware malfunctions.
- Z-0449-2009 · Hologic, Inc. · posted Dec 29, 2008 · Terminated
Software error may lead to a high estimate of major fracture probability.
- Z-0461-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0462-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0463-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0464-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0465-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0466-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0467-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0468-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0469-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0470-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0471-2009 · CAS Medical Systems, Inc. · posted Dec 29, 2008 · Terminated
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Z-0480-2009 · Enterix, Inc. · posted Dec 29, 2008 · Terminated
False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681.
- Z-0459-2009 · Sun Med, Inc. · posted Dec 24, 2008 · Terminated
A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch…
- Z-0621-2009 · Boston Scientific Corporation · posted Dec 24, 2008 · Terminated
For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for…
- Z-0622-2009 · Genico, Inc., dba Genicon · posted Dec 24, 2008 · Terminated
The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.
- Z-0476-2009 · CTS, Inc. dba Guidant Cardiac Surgery · posted Dec 23, 2008 · Terminated
Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.
- Z-0477-2009 · OraSure Technologies, Inc. · posted Dec 23, 2008 · Terminated
Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Z-0478-2009 · OraSure Technologies, Inc. · posted Dec 23, 2008 · Terminated
Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Z-0479-2009 · OraSure Technologies, Inc. · posted Dec 23, 2008 · Terminated
Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
- Z-0524-2009 · Siemens Medical Solutions Diagnostics · posted Dec 23, 2008 · Terminated
Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).
- Z-0486-2009 · FHC, Inc. · posted Dec 22, 2008 · Terminated
Measuring fixture is incorrectly graduated.
- Z-0496-2009 · Thoratec Corp · posted Dec 22, 2008 · Terminated
The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller may result in damage that has the potential to interrupt…
- Z-0500-2009 · Qualigen Inc · posted Dec 22, 2008 · Terminated
The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
- Z-0593-2009 · Irvine Scientific Sales Co Inc · posted Dec 22, 2008 · Terminated
Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
- Z-0412-2009 · Arjo, Inc. · posted Dec 18, 2008 · Terminated
If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
- Z-0413-2009 · Arjo, Inc. · posted Dec 18, 2008 · Terminated
If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
- Z-0481-2009 · OraSure Technologies, Inc. · posted Dec 18, 2008 · Terminated
Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
- Z-0497-2009 · FHC, Inc. · posted Dec 18, 2008 · Terminated
Mislabeled: May contain an electrode longer than labeled size
- Z-0498-2009 · FHC, Inc. · posted Dec 18, 2008 · Terminated
Mislabeled: May contain an electrode longer than labeled size
- Z-0499-2009 · FHC, Inc. · posted Dec 18, 2008 · Terminated
Mislabeled: May contain an electrode longer than labeled size
- Z-0501-2009 · Diagnostica Stago, Inc. · posted Dec 18, 2008 · Terminated
Internal investigation has determined the potential lack of homogeneity between product vials.
- Z-0502-2009 · Diagnostica Stago, Inc. · posted Dec 18, 2008 · Terminated
Internal investigation has determined the potential lack of homogeneity between product vials.
- Z-0509-2009 · Stryker Craniomaxillofacial Division · posted Dec 18, 2008 · Terminated
Lack of assurance of sterility.
- Z-0510-2009 · Stryker Craniomaxillofacial Division · posted Dec 18, 2008 · Terminated
Lack of assurance of sterility.
- Z-0511-2009 · Stryker Craniomaxillofacial Division · posted Dec 18, 2008 · Terminated
Lack of assurance of sterility.
- Z-0512-2009 · Stryker Craniomaxillofacial Division · posted Dec 18, 2008 · Terminated
Lack of assurance of sterility.
- Z-0482-2009 · Alfa Wassermann, Inc. · posted Dec 17, 2008 · Terminated
Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems.
- Z-0338-2009 · Boston Scientific Corporation · posted Dec 16, 2008 · Terminated
Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.
- Z-0454-2009 · Beckman Coulter Inc · posted Dec 16, 2008 · Terminated
Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report. The software error associated…
- Z-0503-2009 · Arjo, Inc. · posted Dec 16, 2008 · Terminated
The battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.
- Z-0504-2009 · Bk Medical · posted Dec 16, 2008 · Terminated
No 510k approved
- Z-0483-2009 · Promega Corpopration · posted Dec 15, 2008 · Terminated
Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl…
- Z-0460-2009 · GE Healthcare Integrated IT Solutions · posted Dec 13, 2008 · Terminated
Software anomalies result in patient safety issues involving patient jacket content intermittently becoming unintentionally out of synchronization with the images being displayed, and involving Default Display Protocols (DDPs) which are used to layout…
- Z-0485-2009 · Dade Behring, Inc. · posted Dec 13, 2008 · Terminated
Reagent may exhibit unflagged inaccurate patient sample results.
- Z-0407-2009 · Mentor Texas, Inc · posted Dec 12, 2008 · Terminated
The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.
- Z-0416-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0417-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0418-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0419-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0420-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0421-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0422-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0423-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0424-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0425-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0426-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0427-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0428-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0429-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0430-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0431-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0432-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0433-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0434-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0435-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0436-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0437-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0438-2009 · C R Bard Inc · posted Dec 12, 2008 · Terminated
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Z-0458-2009 · Integra LifeSciences Corp. · posted Dec 12, 2008 · Terminated
Integra NeuroSciences has become aware that certain Gravity Compensating Accessory implants have the potential for CSF leakage under certain conditions.
- Z-0354-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 11, 2008 · Terminated
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
- Z-0355-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 11, 2008 · Terminated
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
- Z-0356-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 11, 2008 · Terminated
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
- Z-0357-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 11, 2008 · Terminated
Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.
- Z-0447-2009 · Acumed LLC · posted Dec 11, 2008 · Terminated
The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.
- Z-0311-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 10, 2008 · Terminated
The level sensor holder may detach from the adhesive pad causing the sensor to lose contact with the venous reservoir, which may result in a detached sensor indication or false alarm.
- Z-0343-2009 · Advanced Medical Optics, Inc. · posted Dec 10, 2008 · Terminated
Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response…
- Z-0414-2009 · Fisher & Paykel Healthcare Inc · posted Dec 10, 2008 · Terminated
The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day…
- Z-0312-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0313-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0314-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0315-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0316-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0317-2009 · Siemens Medical Solutions USA, Inc · posted Dec 9, 2008 · Terminated
System may switch to emergency fluoroscopy mode.
- Z-0318-2009 · Community Products, LLC · posted Dec 5, 2008 · Terminated
Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in…
- Z-0319-2009 · Mindray DS USA, Inc., dba Datascope Patient Monitoring · posted Dec 5, 2008 · Terminated
Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the…
- Z-0408-2009 · Covidien · posted Dec 4, 2008 · Terminated
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Z-0409-2009 · Covidien · posted Dec 4, 2008 · Terminated
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Z-0410-2009 · Covidien · posted Dec 4, 2008 · Terminated
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Z-0411-2009 · Covidien · posted Dec 4, 2008 · Terminated
Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.
- Z-0324-2009 · Siemens Medical Solutions USA, Inc · posted Dec 3, 2008 · Terminated
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
- Z-0456-2009 · GE Healthcare Integrated IT Solutions · posted Dec 3, 2008 · Terminated
Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may…
- Z-0457-2009 · Radiometer America Inc · posted Dec 3, 2008 · Terminated
The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and…
- Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B ↗Z-0286-2009 · J T Posey Company · posted Dec 2, 2008 · Terminated
Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of…
- Z-0358-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 2, 2008 · Terminated
The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.
- Z-0359-2009 · Terumo Cardiovascular Systems Corporation · posted Dec 2, 2008 · Terminated
The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.
- Z-0441-2009 · Medtronic, Inc. · posted Dec 2, 2008 · Terminated
Failure to insert the guidewire through the 18 gauge introducer needle
- Z-0442-2009 · Medtronic, Inc. · posted Dec 2, 2008 · Terminated
Failure to insert the guidewire through the 18 gauge introducer needle
- Z-0443-2009 · Medtronic, Inc. · posted Dec 2, 2008 · Terminated
Failure to insert the guidewire through the 18 gauge introducer needle
- Z-0444-2009 · Medtronic, Inc. · posted Dec 2, 2008 · Terminated
Failure to insert the guidewire through the 18 gauge introducer needle
- Z-0484-2009 · Advanced Sterilization Products · posted Dec 2, 2008 · Terminated
ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings.
- Z-0298-2009 · Zest Anchors Inc · posted Dec 1, 2008 · Terminated
The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10,…
- Z-0307-2009 · Integra LifeSciences Corp · posted Dec 1, 2008 · Terminated
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate
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.