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FDA-Device2015-01-07Class II

ACCU-CHEK Tender II 17/60 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 de

Roche Diagnostics Operations, Inc.
Hazard

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

Sold states
US Nationwide Distribution
Affected count
Total of 13,041 boxes
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
ACCU-CHEK Tender II 17/60 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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0892-2015

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