Medical device recalls: September 2003
The FDA posted 80 medical device recall records in September 2003, from 32 recall events by 23 companies. 80 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
- Philips Medical Systems · 5 events, 11 records
- Roche Diagnostics Corp. · 3 events, 4 records
- Chattanooga Corp. · 2 events, 2 records
- GE Medical Systems Information Technologies · 2 events, 2 records
- Misys Healthcare Systems · 2 events, 2 records
- International Surgical Supply, Inc. · 1 event, 22 records
- Biomet, Inc. · 1 event, 10 records
- Drug Free Enterprises Inc · 1 event, 5 records
FDA root cause
- Other · 80
Not yet classified (80)
The FDA has posted these records but has not published a class for them yet.
- Z-1281-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1282-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1283-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1284-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1285-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1286-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1287-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1288-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1289-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1290-03 · Biomet, Inc. · posted Sep 24, 2003 · Terminated
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Z-1198-03 · Roche Diagnostics Corp. · posted Sep 23, 2003 · Terminated
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
- Z-1244-03 · Roche Diagnostics Corp. · posted Sep 23, 2003 · Terminated
Lack of assurance of reliability.
- Z-1245-03 · Drug Free Enterprises Inc · posted Sep 23, 2003 · Terminated
Label lacks professional use legend and name and address of the manufacturer.
- Z-1246-03 · Drug Free Enterprises Inc · posted Sep 23, 2003 · Terminated
Label lacks professional use legend and name and address of the manufacturer.
- Z-1253-03 · Drug Free Enterprises Inc · posted Sep 23, 2003 · Terminated
Label lacks professional use legend and name and address of the manufacturer.
- Z-1254-03 · Drug Free Enterprises Inc · posted Sep 23, 2003 · Terminated
Label lacks professional use legend and name and address of the manufacturer.
- Z-1256-03 · Drug Free Enterprises Inc · posted Sep 23, 2003 · Terminated
Label lacks professional use legend and name and address of the manufacturer.
- Z-1257-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1258-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1259-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1260-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1261-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1262-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1263-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1264-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1265-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1266-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1267-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1268-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1269-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1270-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1271-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1272-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1273-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1274-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1275-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1276-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1277-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1278-03 · International Surgical Supply, Inc. · posted Sep 23, 2003 · Terminated
Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Z-1291-03 · GE Medical Systems Information Technologies · posted Sep 23, 2003 · Terminated
The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
- Z-1196-03 · Roche Diagnostics Corp. · posted Sep 17, 2003 · Terminated
Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
- Z-1197-03 · Roche Diagnostics Corp. · posted Sep 17, 2003 · Terminated
Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
- Z-1236-03 · GE Medical Systems Information Technologies · posted Sep 17, 2003 · Terminated
Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
- Z-0985-02 · Multidata Systems Intl Corp · posted Sep 13, 2003 · Terminated
The units lacked the required labels per the laser performace standard.
- Z-1234-03 · Ciba Vision Corporation · posted Sep 13, 2003 · Terminated
Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.
- Z-1235-03 · Blue Torch Medical Technologies · posted Sep 13, 2003 · Terminated
Product's sterility is compromised due to a failed sterility audit
- Z-1199-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
- Z-1200-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
- Z-1201-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
- Z-1202-03 · Varian, Inc. · posted Sep 12, 2003 · Terminated
Stability in question.
- Z-1203-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Spontaneous movement of table without input from an operator
- Z-1204-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Spontaneous movement of table without input from an operator
- Z-1205-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Spontaneous movement of table without input from an operator
- Z-1206-03 · Perkinelmer Life Sciences, Inc. · posted Sep 12, 2003 · Terminated
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
- Z-1207-03 · Perkinelmer Life Sciences, Inc. · posted Sep 12, 2003 · Terminated
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
- Z-1223-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Potential display of an incorrect body part description on patient images.
- Z-1227-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns from cables near or in contact with the patient during use
- Z-1228-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns from cables near or in contact with the patient during use
- Z-1229-03 · Philips Medical Systems · posted Sep 12, 2003 · Terminated
Patient burns from cables near or in contact with the patient during use
- Z-1208-03 · Harvard Clinical Technology · posted Sep 11, 2003 · Terminated
Under specific sequence conditions, the unit may apper to be infusing, but is not
- Z-1210-03 · Chattanooga Corp. · posted Sep 11, 2003 · Terminated
Product contains an improper bracket for the transducer.
- Z-1211-03 · Exactech, Inc. · posted Sep 11, 2003 · Terminated
Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.
- Z-1212-03 · Philips Medical Systems Sales & Service Region No. America · posted Sep 11, 2003 · Terminated
Potential for table to move by itself
- Z-1213-03 · Philips Medical Systems Sales & Service Region No. America · posted Sep 11, 2003 · Terminated
Potential for table to move by itself
- Z-1214-03 · Philips Medical Systems Sales & Service Region No. America · posted Sep 11, 2003 · Terminated
Potential for table to move by itself
- Z-1215-03 · Chattanooga Corp. · posted Sep 11, 2003 · Terminated
Product contains an improper bracket for the transducer.
- Z-1216-03 · Inamed Corp · posted Sep 11, 2003 · Terminated
Labeling mixup.
- Z-1217-03 · Misys Healthcare Systems · posted Sep 11, 2003 · Terminated
Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
- Z-1218-03 · Abbott Laboratories HPD/ADD/GPRD · posted Sep 11, 2003 · Terminated
There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
- Z-1219-03 · Diagnostic Products Corp · posted Sep 11, 2003 · Terminated
Kits had parts in them that did not belong in the kit.
- Z-1220-03 · Misys Healthcare Systems · posted Sep 11, 2003 · Terminated
Software Design Defect. Under certain conditions, results are removed.
- Z-1221-03 · Becton Dickinson & Company · posted Sep 11, 2003 · Terminated
Test Strips may not be meeting specifications at the lower range of glucose values.
- Z-1222-03 · Abiomed, Inc. · posted Sep 11, 2003 · Terminated
Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
- Z-1224-03 · Ortho-Clinical Diagnostics · posted Sep 11, 2003 · Terminated
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in…
- Z-1225-03 · Ortho-Clinical Diagnostics · posted Sep 11, 2003 · Terminated
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.
- Z-1226-03 · Philips Medical Systems · posted Sep 11, 2003 · Terminated
Instructions For Use include addtional information on configuration for selecting Power on Lead
- Z-1230-03 · Bard Endoscopic Technologies · posted Sep 11, 2003 · Terminated
Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Z-1231-03 · Bard Endoscopic Technologies · posted Sep 11, 2003 · Terminated
Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Z-1232-03 · Bard Endoscopic Technologies · posted Sep 11, 2003 · Terminated
Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Z-1233-03 · Bard Endoscopic Technologies · posted Sep 11, 2003 · Terminated
Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
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.