Device recall
Z-0085-2018: Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b)…
FDA device recall · Class II · Bioseal Corporation
Key facts
| Recall number (Z-number) | Z-0085-2018 |
|---|---|
| Recall event | 78375 |
| Product | Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50 |
| Product code | KDD |
| Recalling firm | Bioseal Corporation |
| Recall class | Class II |
| Status | Completed |
| FEI number | 2027062 |
At a glance
- None Linked 510(k)s
- 1–9 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