Device recall
Z-2529-2014: Gown Impervious, Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2529-2014 |
|---|---|
| Recall event | 68536 |
| Product | Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
| Product code | LRO |
| Recalling firm | Customed, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| FEI number | 2648727 |
At a glance
- None Linked 510(k)s
- 100–999 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