Medical device recalls: September 2004
The FDA posted 87 medical device recall records in September 2004, from 41 recall events by 33 companies. 87 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
- Siemens Medical Solutions USA, Inc · 4 events, 7 records
- Abbott Laboratories HPD/ADD/GPRD · 3 events, 3 records
- Roche Diagnostics Corp. · 2 events, 7 records
- Philips Medical Systems Sales & Service Region No. America · 2 events, 6 records
- Datascope Corp · 2 events, 2 records
- Premier Dental Products Co · 1 event, 14 records
- Duro-Med Industries, Inc. · 1 event, 8 records
- Deroyal Surgical -Rose Hill · 1 event, 6 records
FDA root cause
- Other · 87
Not yet classified (87)
The FDA has posted these records but has not published a class for them yet.
- Z-1496-04 · Fisher Diagnostic, A Company of Fisher Scientific LLC · posted Sep 30, 2004 · Terminated
Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
- Z-1497-04 · Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. · posted Sep 30, 2004 · Terminated
5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
- Z-1498-04 · Abbott Laboratories HPD/ADD/GPRD · posted Sep 30, 2004 · Terminated
There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
- Z-1499-04 · PerkinElmer LAS Inc · posted Sep 30, 2004 · Terminated
There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
- Z-1487-04 · Alveolus, Inc. · posted Sep 29, 2004 · Terminated
The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
- Z-1488-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 29, 2004 · Terminated
Potential for patient burn
- Z-1489-04 · Medtronic Inc · posted Sep 29, 2004 · Terminated
Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
- Z-1490-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1491-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1492-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1493-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1494-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1495-04 · Deroyal Surgical -Rose Hill · posted Sep 29, 2004 · Terminated
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Z-1485-04 · Cardinal Health 203, Inc · posted Sep 28, 2004 · Terminated
Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation to the patient.
- Z-1334-04 · Medtronic Inc, Neurological & Spinal Division · posted Sep 23, 2004 · Terminated
With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field,…
- Z-1484-04 · Cryolife Inc · posted Sep 23, 2004 · Terminated
CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.
- Z-1074-04 · Encision, Inc. · posted Sep 22, 2004 · Terminated
Electrosurgical tip may break or come off during use.
- Z-1479-04 · Advanced Sterilization Products · posted Sep 21, 2004 · Terminated
Performance failure complaints.
- Z-1480-04 · Advanced Sterilization Products · posted Sep 21, 2004 · Terminated
Performance failure complaints.
- Z-1481-04 · Advanced Sterilization Products · posted Sep 21, 2004 · Terminated
Performance failure complaints.
- Z-1482-04 · Hill-Rom, Inc. · posted Sep 21, 2004 · Terminated
Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
- Z-1483-04 · Datascope Corp · posted Sep 21, 2004 · Terminated
The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
- Z-1473-04 · Ortho-Clinical Diagnostics · posted Sep 18, 2004 · Terminated
The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.
- Z-1474-04 · Abbott Laboratories HPD/ADD/GPRD · posted Sep 18, 2004 · Terminated
The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.
- Z-1475-04 · Siemens Medical Solutions USA, Inc · posted Sep 18, 2004 · Terminated
X-ray tube movement when table is tilted more than 90 degrees
- Z-1476-04 · Siemens Medical Solutions USA, Inc · posted Sep 18, 2004 · Terminated
X-ray tube movement when table is tilted more than 90 degrees
- Z-1477-04 · Siemens Medical Solutions USA, Inc · posted Sep 18, 2004 · Terminated
possible problem reviewing images on the ACOM.M
- Z-1478-04 · Siemens Medical Solutions USA, Inc · posted Sep 18, 2004 · Terminated
possible problem reviewing images on the ACOM.M
- Z-1472-04 · Zoll Medical Corporation · posted Sep 17, 2004 · Terminated
Visual Sreen display and audible prompt may not advise to 'Press Shock'
- Z-1453-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 15, 2004 · Terminated
Potential for c-arm to move due to loose screws
- Z-1454-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 15, 2004 · Terminated
Potential for c-arm to move due to loose screws
- Z-1455-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 15, 2004 · Terminated
Potential for c-arm to move due to loose screws
- Z-1456-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 15, 2004 · Terminated
Potential for c-arm to move due to loose screws
- Z-1457-04 · Philips Medical Systems Sales & Service Region No. America · posted Sep 15, 2004 · Terminated
Potential for c-arm to move due to loose screws
- Z-1458-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1459-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1460-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1461-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1462-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1463-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1464-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1465-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1466-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1467-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1468-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1469-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1470-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1471-04 · Premier Dental Products Co · posted Sep 15, 2004 · Terminated
foreign objects (polishing stones) in the tubes
- Z-1335-04 · Nipro Diabetes Systems, Inc. · posted Sep 14, 2004 · Terminated
A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.
- Z-1442-04 · Boston Scientific Corporation · posted Sep 14, 2004 · Terminated
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Z-1443-04 · Boston Scientific Corporation · posted Sep 14, 2004 · Terminated
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Z-1444-04 · Boston Scientific Corporation · posted Sep 14, 2004 · Terminated
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Z-1445-04 · Boston Scientific Corporation · posted Sep 14, 2004 · Terminated
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
- Z-1446-04 · Siemens Medical Solutions USA, Inc · posted Sep 14, 2004 · Terminated
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
- Z-1447-04 · Zimmer Inc. · posted Sep 14, 2004 · Terminated
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
- Z-1448-04 · Zimmer Inc. · posted Sep 14, 2004 · Terminated
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
- Z-1449-04 · Siemens Medical Solutions USA, Inc · posted Sep 14, 2004 · Terminated
Opacification Function of device may incorrectly merge images
- Z-1450-04 · Siemens Medical Solutions USA, Inc · posted Sep 14, 2004 · Terminated
Opacification Function of device may incorrectly merge images
- Z-1451-04 · Dana Diabecare USA LLC · posted Sep 14, 2004 · Terminated
There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
- Z-1452-04 · Abbott Laboratories HPD/ADD/GPRD · posted Sep 14, 2004 · Terminated
Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.
- Z-1439-04 · B. Braun Medical, Inc. · posted Sep 9, 2004 · Terminated
drug ampuls in kits contain particulates
- Z-1440-04 · B. Braun Medical, Inc. · posted Sep 9, 2004 · Terminated
drug ampuls in kits contain particulates
- Z-1441-04 · Datascope Corp · posted Sep 9, 2004 · Terminated
Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
- Z-1438-04 · U&I America · posted Sep 8, 2004 · Terminated
Threads on a set screw, as a component of a spinal fixation system, may break off during use.
- Z-1414-04 · Nellcor Puritan Bennett · posted Sep 2, 2004 · Terminated
The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
- Z-1428-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.
- Z-1429-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Z-1430-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Z-1431-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Z-1432-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Z-1433-04 · Beckman Coulter Inc · posted Sep 2, 2004 · Terminated
Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.
- Z-1434-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
- Z-1435-04 · Roche Diagnostics Corp. · posted Sep 2, 2004 · Terminated
Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
- Z-1436-04 · Abbott Health Products, Inc. · posted Sep 2, 2004 · Terminated
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
- Z-1437-04 · Biosense Webster, Inc. · posted Sep 2, 2004 · Terminated
Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
- Z-1415-04 · TissueLink Medical, Inc. · posted Sep 1, 2004 · Terminated
Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
- Z-1416-04 · TissueLink Medical, Inc. · posted Sep 1, 2004 · Terminated
Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
- Z-1417-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1418-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1419-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1420-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1421-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1422-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1423-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1424-04 · Duro-Med Industries, Inc. · posted Sep 1, 2004 · Terminated
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
- Z-1425-04 · St. Jude Medical/Daig Division · posted Sep 1, 2004 · Terminated
St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm…
- Z-1426-04 · St. Jude Medical/Daig Division · posted Sep 1, 2004 · Terminated
St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm…
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.