ACCU-CHEK Tender II 17/80 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.
This recall has been terminated (originally issued December 30, 2014).
- Recall Initiated
- November 20, 2014
- Posted
- December 30, 2014
- Terminated
- January 10, 2018
- Recall Number
- Z-0893-2015
- Quantity
- Total of 13,041 boxes
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
US Nationwide Distribution
Lot / Code Info
Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
Root Cause
Device Design
Action Taken
Roche sent the "Urgent Medical Device Corrections" letter dated 12/1/2014 via UPS Ground (receipt required) to the Patients, and Distributors who received the affected device. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Pump Support at 1-800-688-4578.