Roche Diagnostics Operations, Inc. recalls ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the b…

Recall date

November 20, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0890-2015

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.