Device recall
Z-2252-2013: Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit…
FDA device recall · Class II · Churchill Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2252-2013 |
|---|---|
| Recall event | 66060 |
| Product | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing… |
| Product code | FPA |
| Recalling firm | Churchill Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2014 |
| 510(k) numbers | K963981 |
| FEI number | 1000120555 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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