Medical Devices Recalls

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

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.

Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

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.

Insulin syringe retail packages incorrectly labeled as "Short Needle".

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.

Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation

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.