Device product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Z-2246-2017
Product summary
- Event
- Event 76394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,048
- Official record key
device-enforcement:Z-2246-2017
Official wording
Reason: Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
Code information: Product Code 5C4483; Lot# H12030047
Distribution pattern: Nationwide Distribution and Internationally to Canada and Malaysia
Derived failure modes
-
Unknown
Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.