Device recall
Z-2384-2014: PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1)…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2384-2014 |
|---|---|
| Recall event | 68536 |
| Product | PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF… |
| Product code | FHI |
| 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
- 10–99 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