FDA Device recall Z-2252-2013
Central Dressing Change Kit
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Central Dressing Change Kit by Churchill Medical Systems, citing microbore tubing disconnecting from male luers on the extension sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2252-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-12 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Churchill Medical Systems |
| Distribution | US |
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 Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG, 2 1/2" X 4 1/2" *** Vygon MFG Dover, NH 03820***"
Reason
Microbore tubing disconnecting from male luers on the extension sets.
Identifiers
| code_info | Lot Numbers: 1303022, 1304065 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2252-2013%22
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