Device recall
Z-1487-2011: ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC…
FDA device recall · Class I · Roche Insulin Delivery Systems Inc.
Key facts
| Recall number (Z-number) | Z-1487-2011 |
|---|---|
| Recall event | 58015 |
| Product | ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc… |
| Product code | FRN |
| Recalling firm | Roche Insulin Delivery Systems Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 27, 2011 |
| 510(k) numbers | K100704 |
| FEI number | 1000116163 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database