Medical device recalls: July 2003
The FDA posted 113 medical device recall records in July 2003, from 63 recall events by 47 companies. 113 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 · 6 events, 6 records
- Boston Scientific Corporation · 3 events, 6 records
- Misys Healthcare Systems · 3 events, 3 records
- Roche Diagnostics Corp. · 3 events, 3 records
- Zeus Scientific Inc · 3 events, 3 records
- Deltec, Inc · 2 events, 4 records
- PerkinElmer Life Sciences Inc · 2 events, 4 records
- Cryolife Inc · 2 events, 2 records
FDA root cause
- Other · 112
- Labeling False and Misleading · 1
Not yet classified (113)
The FDA has posted these records but has not published a class for them yet.
- Z-1065-03 · Zeus Scientific Inc · posted Jul 30, 2003 · Terminated
The high positive control/low positive standard ratio recovering too low.
- Z-1066-03 · Deltec, Inc · posted Jul 30, 2003 · Terminated
Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
- Z-1067-03 · Deltec, Inc · posted Jul 30, 2003 · Terminated
Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
- Z-1068-03 · Deltec, Inc · posted Jul 30, 2003 · Terminated
Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.
- Z-1069-03 · Encore Medical, LP · posted Jul 30, 2003 · Terminated
Product container was labeled incorrectly indicating left femur instead of right.
- Z-1071-03 · Beckman Coulter Inc · posted Jul 30, 2003 · Terminated
Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has…
- Z-1072-03 · Diametrics Medical, Inc. · posted Jul 30, 2003 · Terminated
An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
- Z-0921-03 · Stryker Instruments, Instruments Div. · posted Jul 29, 2003 · Terminated
Non-sterilized product sold as sterile.
- Z-1053-03 · LMA North America Inc · posted Jul 29, 2003 · Terminated
Sterility cannot be assured
- Z-1054-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Bottle contains less product than is declared on the label.
- Z-1055-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Vial contains less product than is declared on the label.
- Z-1056-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Vial contains less product than is declared on the label.
- Z-1057-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Vial contains less product than is declared on the label.
- Z-1058-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Vial contains less product than is declared on the label.
- Z-1059-03 · Cook, Inc. · posted Jul 29, 2003 · Terminated
Vial contains less product than is declared on the label.
- Z-1060-03 · Medex Inc · posted Jul 29, 2003 · Terminated
Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
- Z-1061-03 · Boston Scientific Corporation · posted Jul 29, 2003 · Terminated
Sterility of the device may be compromised due to a lack of package integrity
- Z-1062-03 · Boston Scientific Corporation · posted Jul 29, 2003 · Terminated
Sterility of the device may b e compromised due to a lack of package integrity
- Z-1063-03 · Boston Scientific Corporation · posted Jul 29, 2003 · Terminated
Sterility of the device may b e compromised due to a lack of package integrity
- Z-1064-03 · Ohmeda Medical, A division of Datex-Ohmeda, Inc. · posted Jul 29, 2003 · Terminated
Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
- Z-1020-03 · Cardinal Health · posted Jul 24, 2003 · Terminated
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- Catalog SBA21MAHVJ, Sterile Major Abdominal Pack, Mfg date 5/22/03, Exp date 1/01/05, order 101491 ↗Z-1021-03 · Cardinal Health · posted Jul 24, 2003 · Terminated
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- Z-1022-03 · Cardinal Health · posted Jul 24, 2003 · Terminated
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- Z-1023-03 · Cardinal Health · posted Jul 24, 2003 · Terminated
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- Z-1024-03 · Cardinal Health · posted Jul 24, 2003 · Terminated
The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.
- Z-1045-03 · Henry Schein, Inc. · posted Jul 24, 2003 · Terminated
FDA's analysis revealed defects (holes) in the latex gloves.
- Z-1046-03 · Henry Schein, Inc. · posted Jul 24, 2003 · Terminated
FDA's analysis revealed defects (holes) in the latex gloves.
- Z-1047-03 · Abbott Laboratories HPD/ADD · posted Jul 24, 2003 · Terminated
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
- Z-1048-03 · Power Medical Interventions · posted Jul 24, 2003 · Terminated
latching mechanism failure
- Z-1049-03 · Power Medical Interventions · posted Jul 24, 2003 · Terminated
latching mechanism failure
- Z-1050-03 · Encision, Inc. · posted Jul 24, 2003 · Terminated
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- Z-1051-03 · Encision, Inc. · posted Jul 24, 2003 · Terminated
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- Z-1052-03 · Encision, Inc. · posted Jul 24, 2003 · Terminated
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
- Z-1039-03 · Portex Inc. · posted Jul 23, 2003 · Terminated
Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
- Z-1040-03 · Depuy Orthopaedics, Inc. · posted Jul 23, 2003 · Terminated
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Z-1041-03 · Depuy Orthopaedics, Inc. · posted Jul 23, 2003 · Terminated
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Z-1042-03 · Depuy Orthopaedics, Inc. · posted Jul 23, 2003 · Terminated
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Z-1043-03 · Depuy Orthopaedics, Inc. · posted Jul 23, 2003 · Terminated
Lack of assurance of sterility, due to the possibility of an incomplete package seal.
- Z-1044-03 · Roche Diagnostics Corp. · posted Jul 23, 2003 · Terminated
A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
- Z-1036-03 · Allergan Medical Optics Inc · posted Jul 22, 2003 · Terminated
Post operative complaints of cloudiness in the intraocular lenses.
- Z-1037-03 · Quest Medical, Inc · posted Jul 22, 2003 · Terminated
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
- Z-1038-03 · Cryolife Inc · posted Jul 22, 2003 · Terminated
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
- Z-0991-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0992-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0993-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0994-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0995-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0996-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0997-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0998-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-0999-03 · Portex Ltd. · posted Jul 19, 2003 · Terminated
Tracheal tubes may be non-sterile
- Z-1029-03 · Siemens Medical Solutions USA, Inc · posted Jul 19, 2003 · Terminated
software issue. New examinations may not be saved properly and the examination may be lost.
- Z-1030-03 · Roche Diagnostics Corp. · posted Jul 19, 2003 · Terminated
Test results may exhibit a positive bias when plasma samples are used for the assay.
- Z-1031-03 · Zeus Scientific Inc · posted Jul 19, 2003 · Terminated
Calibrator C not meeting its optical density specification.
- Z-1032-03 · Siemens Medical Solutions USA, Inc · posted Jul 19, 2003 · Terminated
Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
- Z-1033-03 · Boston Scientific Corporation · posted Jul 19, 2003 · Terminated
Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
- Z-1034-03 · Boston Scientific Corporation · posted Jul 19, 2003 · Terminated
Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
- Z-1035-03 · Arrow International Inc · posted Jul 19, 2003 · Terminated
separation of sheath
- Z-1027-03 · Hill-Rom, Inc. · posted Jul 18, 2003 · Terminated
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
- Z-1028-03 · Hill-Rom, Inc. · posted Jul 18, 2003 · Terminated
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
- Z-1025-03 · Vail Products Inc · posted Jul 17, 2003 · Terminated
Patients may become entrapped between the bottom side rail and mattress.
- Z-1026-03 · Vail Products Inc · posted Jul 17, 2003 · Terminated
Patients may become entrapped between the bottom side rail and mattress.
- Z-1001-03 · Roche Diagnostics Corp. · posted Jul 15, 2003 · Terminated
Potential for false negative patient results with software version 3.0
- Z-1002-03 · Coapt Systems, Inc. · posted Jul 15, 2003 · Terminated
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
- Z-1003-03 · Life-Tech International, Inc · posted Jul 15, 2003 · Terminated
Catheter does not fit through the needle resulting in delay of medical procedure
- Z-1004-03 · Mitek Worldwide · posted Jul 15, 2003 · Terminated
Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
- Z-1005-03 · Mitek Worldwide · posted Jul 15, 2003 · Terminated
Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm
- Z-1006-03 · Ebi, L.P. · posted Jul 15, 2003 · Terminated
Non sterile device is labeled sterile.
- Z-1007-03 · Misys Healthcare Systems · posted Jul 15, 2003 · Terminated
Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
- Z-1008-03 · Sanarus Medical Inc · posted Jul 15, 2003 · Terminated
Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
- Z-1009-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1010-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1011-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1012-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1013-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1014-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1015-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1016-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1017-03 · Guidant Corp-Cpi Division · posted Jul 15, 2003 · Terminated
Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Z-1018-03 · Elite Medical Group · posted Jul 15, 2003 · Terminated
The liquid tissue adhesive was marketed without FDA pre-market clearance.
- Z-1019-03 · Boston Scientific Corporation · posted Jul 15, 2003 · Terminated
Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
- Z-0987-03 · Siemens Medical Solutions USA, Inc · posted Jul 10, 2003 · Terminated
the back up safety catch may not function properly
- Z-0988-03 · Cryolife Inc · posted Jul 10, 2003 · Terminated
Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.
- Z-0989-03 · Hill-Rom Manufacturing, Inc. · posted Jul 10, 2003 · Terminated
Malfunction of side-rail latching pin coupled with inadequate directions for use.
- Z-0990-03 · Hill-Rom Manufacturing, Inc. · posted Jul 10, 2003 · Terminated
Malfunction of side-rail latching pin coupled with inadequate directions for use.
- Z-1000-03 · Zoll Medical Corporation · posted Jul 10, 2003 · Terminated
Defibrillator may fail to charge or hold its charge above energies of 75 joules
- Z-0982-03 · Ventlab Corporation · posted Jul 8, 2003 · Terminated
Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
- Z-0983-03 · Numed Inc · posted Jul 8, 2003 · Terminated
Lacks a PMA or 510k.
- Z-0984-03 · Siemens Medical Solutions USA, Inc · posted Jul 8, 2003 · Terminated
software malfunction. May indicate that the image is flipped when it is not.
- Z-0985-03 · Ethicon Endo-Surgery · posted Jul 8, 2003 · Terminated
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- Z-0986-03 · Ethicon Endo-Surgery · posted Jul 8, 2003 · Terminated
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- Z-0976-03 · Siemens Medical Solutions USA, Inc · posted Jul 3, 2003 · Terminated
OR Table stops during the transfer of the table to the MR system and will not move.
- Z-0978-03 · Coopervision Inc · posted Jul 3, 2003 · Terminated
The actual sphere power of the lens is lower than the labeled value.
- Z-0979-03 · Siemens Medical Solutions USA, Inc · posted Jul 3, 2003 · Terminated
software problem - erroneous results or system crashes
- Z-0980-03 · Deltec, Inc · posted Jul 3, 2003 · Terminated
Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
- Z-0981-03 · A.R.C. Laser Corp · posted Jul 3, 2003 · Terminated
Product may not have been properly sterilized.
- Z-0960-03 · Cobe Cardiovascular, Inc · posted Jul 2, 2003 · Terminated
Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
- Z-0961-03 · Zeus Scientific Inc · posted Jul 2, 2003 · Terminated
Mix-up between low positive and negative controls.
- Z-0962-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0963-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0964-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0965-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0966-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0967-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0968-03 · MedAmicus,Inc · posted Jul 2, 2003 · Terminated
Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Z-0969-03 · PerkinElmer Life Sciences Inc · posted Jul 2, 2003 · Terminated
The device is not stable throughout its labeled expiration date.
- Z-0970-03 · PerkinElmer Life Sciences Inc · posted Jul 2, 2003 · Terminated
The device is not stable throughout its labeled expiration date.
- Z-0971-03 · PerkinElmer Life Sciences Inc · posted Jul 2, 2003 · Terminated
The device is not stable throughout its labeled expiration date.
- Z-0972-03 · Misys Healthcare Systems · posted Jul 2, 2003 · Terminated
Abnormal results are flagged as normal.
- Z-0973-03 · PerkinElmer LIfe Sciences Inc · posted Jul 2, 2003 · Terminated
The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
- Z-0974-03 · Misys Healthcare Systems · posted Jul 2, 2003 · Terminated
Susceptibility comments are ommited from Microbiology cumulative reports
- Z-0975-03 · Siemans Medial Solutions USA, Inc · posted Jul 2, 2003 · Terminated
software problem - loss of data
- Z-0951-03 · Respironics California Inc · posted Jul 1, 2003 · Terminated
Material hardness on original design check valve may cause premature failure.
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.