Device recall
Z-2528-2014: Laparoscopy pack,, Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10)…
FDA device recall · Class I · Customed, Inc
Key facts
| Recall number (Z-number) | Z-2528-2014 |
|---|---|
| Recall event | 68536 |
| Product | Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE VIDEO CAMERA 13cm X… |
| Product code | FDE |
| 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
- 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