Device recall
Z-2687-2017: Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF…
FDA device recall · Class II · Mallinckrodt Manufacturing LLC
Key facts
| Recall number (Z-number) | Z-2687-2017 |
|---|---|
| Recall event | 77482 |
| Product | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery. |
| Product code | NBE |
| Recalling firm | Mallinckrodt Manufacturing LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2017 |
| PMA numbers | P100030 |
| FEI number | 3006472186 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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