Roche Diagnostics Operations, Inc. Recall: ACCU-CHEK Tender II 13/110 10 + 10 pieces Produ
Roche Diagnostics Operations, Inc. Recall: ACCU-CHEK Tender II 13/110 10 + 10 pieces Produ is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Operations, Inc.; Product: ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of
| Recalling firm | Roche Diagnostics Operations, Inc. |
|---|---|
| Product | ACCU-CHEK Tender II 13/110 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 |
| 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide Distribution |
| Recall initiated | 20141120 |
| Recall number | Z-0891-2015 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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