Device recall
Z-0637-2018: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B…
FDA device recall · Class II · DeRoyal Industries Inc
Key facts
| Recall number (Z-number) | Z-0637-2018 |
|---|---|
| Recall event | 79052 |
| Product | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy |
| Product code | LRO |
| Recalling firm | DeRoyal Industries Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| 510(k) numbers | K842648 |
| FEI number | 1043214 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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