Device recall
Z-2221-2019: Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled…
FDA device recall · Class II · ROi Consolidated Service Center (CSC)
Key facts
| Recall number (Z-number) | Z-2221-2019 |
|---|---|
| Recall event | 82499 |
| Product | Regard custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP. |
| Product code | KDD |
| Recalling firm | ROi Consolidated Service Center (CSC) |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004513970 |
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