All Recalls

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of assurance of sterility

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of assurance of sterility

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.

Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.

Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.

Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.