Device recall
Z-0443-03: Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room…
FDA device recall · Class II · Sterile Surgical Systems Llc
Key facts
| Recall number (Z-number) | Z-0443-03 |
|---|---|
| Recall event | 25118 |
| Product | Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' re-usable wrappers, 1 24'' re-usable wrappers Surgical gown packs, inside double wrappers, for use in… |
| Product code | FYA |
| Recalling firm | Sterile Surgical Systems Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2003 |
| FEI number | 1000307344 |
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