Device product
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
Z-1565-2013
Product summary
- Event
- Event 65254
- Status
- Terminated
- Classification
- Class II
- Quantity
- 629,280 units
- Official record key
device-enforcement:Z-1565-2013
Official wording
Reason: leaking pouches
Code information: Lot Number GD893891
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
leaking pouches