Device product
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Z-2074-2014
Product summary
- Event
- Event 68590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 585,360 units
- Official record key
device-enforcement:Z-2074-2014
Official wording
Reason: Inadequate iodine and packaging related defects.
Code information: GD895771
Distribution pattern: Distributed USA (nationwide) and Canada.
Derived failure modes
-
Unknown
Inadequate iodine and packaging related defects.