Device 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***"
Z-2252-2013
Product summary
- Event
- Event 66060
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3040
- Official record key
device-enforcement:Z-2252-2013
Official wording
Reason: Microbore tubing disconnecting from male luers on the extension sets.
Code information: Lot Numbers: 1303022, 1304065
Distribution pattern: Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
Derived failure modes
-
Unknown
Microbore tubing disconnecting from male luers on the extension sets.