Other Medical Devices

An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.