Device product
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Z-1269-2015
Product summary
- Event
- Event 70512
- Status
- Completed
- Classification
- Class II
- Quantity
- 4,391,520 units
- Official record key
device-enforcement:Z-1269-2015
Official wording
Reason: Product may have separating or protruding sponges
Code information: Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015
Distribution pattern: Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
Derived failure modes
-
Unknown
Product may have separating or protruding sponges