Medical device recalls: August 2003
The FDA posted 123 medical device recall records in August 2003, from 49 recall events by 40 companies. 123 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
- Boston Scientific Scimed · 3 events, 27 records
- Misys Healthcare Systems · 3 events, 3 records
- Abbott Laboratories, Inc · 2 events, 2 records
- Beckman Coulter Inc · 2 events, 2 records
- Cryolife Inc · 2 events, 2 records
- Philips Medical Systems · 2 events, 2 records
- Zeus Scientific Inc · 2 events, 2 records
- Baxter Healthcare Corp. · 1 event, 29 records
FDA root cause
- Other · 123
Not yet classified (123)
The FDA has posted these records but has not published a class for them yet.
- Z-1188-03 · Cryolife Inc · posted Aug 29, 2003 · Terminated
CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
- Z-1189-03 · Boston Scientific Scimed · posted Aug 29, 2003 · Terminated
Some of the recalled catheters may be in pouches with incomplete seals.
- Z-1190-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-1191-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-1192-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-1193-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-1194-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-1195-03 · Terumo Cardiovascular Systems Corp · posted Aug 29, 2003 · Terminated
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Z-0937-03 · Datex-Ohmeda Inc · posted Aug 28, 2003 · Terminated
Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
- Z-1186-03 · Wright Medical Technology Inc · posted Aug 28, 2003 · Terminated
Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation.
- Z-1187-03 · Cryolife Inc · posted Aug 28, 2003 · Terminated
Donor of aortic valve had procurement cultures that were positive for E-coli.
- Z-1182-03 · U&I America · posted Aug 27, 2003 · Terminated
Reports of pieces chipping off the tip of screwdriver during use.
- Z-1183-03 · U&I America · posted Aug 27, 2003 · Terminated
Reports of pieces chipping off the tip of screwdriver during use.
- Z-1184-03 · Conmed Corporation · posted Aug 27, 2003 · Terminated
Separation of the sensing element from the body of the electrode.
- Z-1185-03 · Conmed Corporation · posted Aug 27, 2003 · Terminated
Separation of the sensing element from the body of the electrode.
- Z-0977-03 · Watson Diagnostics Inc. · posted Aug 26, 2003 · Terminated
Lights split, spilling contents when bent to activate.
- Z-1146-03 · Exactech, Inc. · posted Aug 26, 2003 · Terminated
The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.
- Z-1179-03 · Wilson-Cook Medical Inc · posted Aug 26, 2003 · Terminated
The inner catheter of the introducer system may break after stent deployment.
- Z-1180-03 · Wilson-Cook Medical Inc · posted Aug 26, 2003 · Terminated
The inner catheter of the introducer system may break after stent deployment.
- Z-1181-03 · Wilson-Cook Medical Inc · posted Aug 26, 2003 · Terminated
The inner catheter of the introducer system may break after stent deployment.
- Z-1070-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1142-03 · Abbott Laboratories, Inc · posted Aug 21, 2003 · Terminated
ICT assays run using a manual dilution will not be calculated correctly by the software.
- Z-1143-03 · Stryker Howmedica Osteonics · posted Aug 21, 2003 · Terminated
Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.
- Z-1144-03 · C.R. Bard, Inc., Urological Division · posted Aug 21, 2003 · Terminated
On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
- Z-1145-03 · Hill-Rom Co., Inc. · posted Aug 21, 2003 · Terminated
The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- Z-1147-03 · Zeus Scientific Inc · posted Aug 21, 2003 · Terminated
Bacterial contamination of the high positive control.
- Z-1148-03 · Beckman Coulter Inc · posted Aug 21, 2003 · Terminated
Defective software media distributed with upgrade software may cause installation failure and systems lock.
- Z-1149-03 · ABX Diagnostics Inc · posted Aug 21, 2003 · Terminated
Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
- Z-1150-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1151-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1152-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1153-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1154-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1155-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1156-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1157-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1158-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1159-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1160-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1161-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1162-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1163-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1164-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1165-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1166-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1167-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1168-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1169-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1171-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1172-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1173-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1174-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1175-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1176-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1177-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1178-03 · Baxter Healthcare Corp. · posted Aug 21, 2003 · Terminated
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Z-1298-03 · Hill-Rom Co., Inc. · posted Aug 21, 2003 · Terminated
The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- Z-1299-03 · Hill-Rom Co., Inc. · posted Aug 21, 2003 · Terminated
The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
- Z-1094-03 · Becton Dickinson & Co. · posted Aug 20, 2003 · Terminated
Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
- Z-1138-03 · DPC Cirrus · posted Aug 20, 2003 · Terminated
Version 2.6 software was released however it will not properly handle adjustment slopes.
- Z-1139-03 · PerkinElmer Life Sciences Inc · posted Aug 20, 2003 · Terminated
The kits are producing lower values than expected, which may result in an increase of false positive test results.
- Z-1140-03 · Perkinelmer Life Sciences, Inc. · posted Aug 20, 2003 · Terminated
Product's outer carton label was labeled with an extended expiration date
- Z-1141-03 · Abbott Vascular Devices · posted Aug 20, 2003 · Terminated
The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
- Z-1137-03 · Molnlycke Health Care Inc · posted Aug 14, 2003 · Terminated
pouch may tear which could result in contamination of sterile field
- Z-1129-03 · Abbott Laboratories HPD/ADD/GPRD · posted Aug 13, 2003 · Terminated
The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
- Z-1130-03 · Abbott Laboratories HPD/ADD · posted Aug 13, 2003 · Terminated
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
- Z-1131-03 · Abbott Laboratories HPD/ADD · posted Aug 13, 2003 · Terminated
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
- Z-1132-03 · Abbott Laboratories HPD/ADD · posted Aug 13, 2003 · Terminated
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
- Z-1133-03 · Abbott Laboratories, Inc · posted Aug 13, 2003 · Terminated
Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
- Z-1095-03 · Zeus Scientific Inc · posted Aug 12, 2003 · Terminated
The Calibrator included within the kit may be losing reactivity.
- Z-1096-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1097-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1098-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1099-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1100-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1101-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1102-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1103-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1104-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1105-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1106-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1107-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1108-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1109-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1110-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1111-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1112-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1113-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1114-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1115-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1116-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1117-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1118-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1119-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1120-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
Some of the product pouches have holes in the seals.
- Z-1121-03 · Valleylab, Inc · posted Aug 12, 2003 · Terminated
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
- Z-1122-03 · Valleylab, Inc · posted Aug 12, 2003 · Terminated
Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
- Z-1123-03 · Boston Scientific Scimed · posted Aug 12, 2003 · Terminated
There is an Increased potential for broken struts of the stents.
- Z-1124-03 · Intralase Corp · posted Aug 12, 2003 · Terminated
Gantry moves toward patient when 'Home' button is used after procedure.
- Z-1125-03 · Philips Medical Systems · posted Aug 12, 2003 · Terminated
If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
- Z-1126-03 · Olympus America Inc. · posted Aug 12, 2003 · Terminated
Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.
- Z-1127-03 · Meridian Bioscience Inc · posted Aug 12, 2003 · Terminated
The Low Positive Standard kit component is losing potency that may result in false positive test results.
- Z-1128-03 · Philips Medical Systems · posted Aug 12, 2003 · Terminated
Potential for incorrect body part information
- Z-1087-03 · Siemens Medical Solutions USA, Inc · posted Aug 7, 2003 · Terminated
software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Z-1088-03 · Siemens Medical Solutions USA, Inc · posted Aug 7, 2003 · Terminated
software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Z-1089-03 · Siemens Medical Solutions USA, Inc · posted Aug 7, 2003 · Terminated
software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Z-1090-03 · Misys Healthcare Systems · posted Aug 7, 2003 · Terminated
Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
- Z-1091-03 · Coopervision Inc · posted Aug 7, 2003 · Terminated
Mislabeled with incorrect sphere power.
- Z-1092-03 · Misys Healthcare Systems · posted Aug 7, 2003 · Terminated
Patient files become mixed up due to a software defect.
- Z-1093-03 · Misys Healthcare Systems · posted Aug 7, 2003 · Terminated
Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
- Z-1076-03 · Hardy Media Inc Dba Hardy Diag · posted Aug 6, 2003 · Terminated
Customers complained of bacterial contamination of lot A10-3155A.
- Z-1077-03 · Beckman Coulter Inc · posted Aug 6, 2003 · Terminated
Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
- Z-1078-03 · Alcon Laboratories, Inc. · posted Aug 6, 2003 · Terminated
Software error could, under specific circumstances, allow the patient's centration images and data to be stored incorrectly.
- Z-1079-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1080-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1081-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1082-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1083-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1084-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1085-03 · Ballard Medical Products · posted Aug 6, 2003 · Terminated
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
- Z-1086-03 · Fresenius Hemocare, Inc. · posted Aug 6, 2003 · Terminated
No package insert
- Z-1074-03 · Rx Textiles Inc · posted Aug 1, 2003 · Terminated
Product may not be sterile.
- Z-1075-03 · Guidant Corporation ACS · posted Aug 1, 2003 · Terminated
Potential loss of package sterility.
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.