Medical device recalls: November 2003
The FDA posted 47 medical device recall records in November 2003, from 30 recall events by 25 companies. 47 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
- Merit Medical Systems, Inc · 2 events, 8 records
- Arrow International Inc · 2 events, 4 records
- Beckman Coulter Inc · 2 events, 2 records
- Medtronic MiniMed · 2 events, 2 records
- Plus Orthopedics · 2 events, 2 records
- Anika Therapeutics · 1 event, 6 records
- Philips Medical Systems (Cleveland) Inc · 1 event, 3 records
- Terumo Cardiovascular Systems Corp · 1 event, 2 records
FDA root cause
- Other · 47
Not yet classified (47)
The FDA has posted these records but has not published a class for them yet.
- Z-0158-04 · Merit Medical Systems, Inc · posted Nov 27, 2003 · Terminated
Angiographic catheter tips may separate during use.
- Z-0159-04 · Merit Medical Systems, Inc · posted Nov 27, 2003 · Terminated
Angiographic catheter tips may separate during use.
- Z-0160-04 · Vygon US LLC · posted Nov 27, 2003 · Terminated
mislabeled as sterile
- Z-0161-04 · Vygon US LLC · posted Nov 27, 2003 · Terminated
mislabeled as sterile
- Z-0164-04 · Becton Dickinson & Co · posted Nov 27, 2003 · Terminated
Microbiological media may exhibit reduced colony size of bacteria, Haemophilus species.
- Z-0166-04 · Portex Inc · posted Nov 27, 2003 · Terminated
Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
- Z-0167-04 · Cryolife Inc · posted Nov 27, 2003 · Terminated
CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting…
- Z-0168-04 · Medtronic MiniMed · posted Nov 27, 2003 · Terminated
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
- Z-0169-04 · Medtronic MiniMed · posted Nov 27, 2003 · Terminated
Non delivery of insulin by pump after electrostatic discharge.
- Z-0170-04 · Plus Orthopedics · posted Nov 27, 2003 · Terminated
Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
- Z-0115-04 · Ventana Medical Systems Inc · posted Nov 19, 2003 · Terminated
Increased level of non-specific or background staining.
- Z-0136-04 · Beckman Coulter Inc · posted Nov 19, 2003 · Terminated
Labeling Error-Omission of 'Research Use Only'
- Z-0137-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0138-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0139-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0140-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0141-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0142-04 · Merit Medical Systems, Inc · posted Nov 19, 2003 · Terminated
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
- Z-0144-04 · ConMed Electrosurgery · posted Nov 19, 2003 · Terminated
The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
- Z-0106-04 · Cti Pet Systems Inc · posted Nov 13, 2003 · Terminated
CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
- Z-0107-04 · Plus Orthopedics · posted Nov 13, 2003 · Terminated
Plastic insert over articular surface of knee joint replacement may become dislodged.
- Z-0108-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0109-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0110-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0111-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0112-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0113-04 · Anika Therapeutics · posted Nov 13, 2003 · Terminated
Stability failure at the 20 month for viscosity specification
- Z-0114-04 · Medline Industries Inc · posted Nov 13, 2003 · Terminated
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
- Z-0104-04 · Sandhill Scientific, Inc · posted Nov 11, 2003 · Terminated
Pouch containing pediatric probes was labeled as containing adult probes.
- Z-0105-04 · Exactech, Inc. · posted Nov 11, 2003 · Terminated
Instrument is excessively flexible making it unusable by the surgeon.
- Z-0102-04 · Terumo Cardiovascular Systems Corp · posted Nov 7, 2003 · Terminated
The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
- Z-0103-04 · Terumo Cardiovascular Systems Corp · posted Nov 7, 2003 · Terminated
The roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
- Z-0089-04 · Wilson-Cook Medical Inc · posted Nov 6, 2003 · Terminated
Complaints were reported of difficulty in stent deployment.
- Z-0090-04 · Qualigen Inc · posted Nov 6, 2003 · Terminated
Kits may produce results that are falsely elevated.
- Z-0092-04 · General Electric Medical Systems Information Technology · posted Nov 6, 2003 · Terminated
Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.
- Z-0093-04 · Philips Medical Systems (Cleveland) Inc · posted Nov 6, 2003 · Terminated
Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
- Z-0094-04 · Philips Medical Systems (Cleveland) Inc · posted Nov 6, 2003 · Terminated
Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
- Z-0095-04 · Philips Medical Systems (Cleveland) Inc · posted Nov 6, 2003 · Terminated
Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.
- Z-0096-04 · Beckman Coulter Inc · posted Nov 6, 2003 · Terminated
Sample wheel may home to the wrong position.
- Z-0098-04 · Bard Access Systems, Inc · posted Nov 6, 2003 · Terminated
Sterility of product is compromised by open seals in packaging.
- Z-0100-04 · Toshiba American Med Sys Inc · posted Nov 6, 2003 · Terminated
Images display with wrong patient demographics.
- Z-0101-04 · Vascular Solutions, Inc · posted Nov 6, 2003 · Terminated
An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.
- Z-0082-04 · Arrow International Inc · posted Nov 1, 2003 · Terminated
wrong product in box
- Z-0083-04 · Arrow International Inc · posted Nov 1, 2003 · Terminated
wrong product in box
- Z-0084-04 · Arrow International Inc · posted Nov 1, 2003 · Terminated
wrong product in box
- Z-0087-04 · Rita Medical Systems · posted Nov 1, 2003 · Terminated
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
- Z-0088-04 · Arrow International Inc · posted Nov 1, 2003 · Terminated
package lid identifies the contents incorrectly
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.