Device recall
Z-1422-2012: Sterile sterile surgical kits containing Episeal products, packaged as follows…
FDA device recall · Class III · Deroyal Industries, Inc. Lafollette
Key facts
| Recall number (Z-number) | Z-1422-2012 |
|---|---|
| Recall event | 61403 |
| Product | Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by… |
| Product code | KDD |
| Recalling firm | Deroyal Industries, Inc. Lafollette |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 10, 2013 |
| FEI number | 3005011024 |
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