ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the b
FDA device recall Z-0883-2015 · posted 2014-12-30 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- Total of 13,041 boxes
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-11-20
- Date posted
- 2014-12-30
- Date terminated
- 2018-01-10
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET (K972135) | P/L Biomedical | 1997-08-26 |