Device product
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Z-0969-2013
Product summary
- Event
- Event 64471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 sets
- Official record key
device-enforcement:Z-0969-2013
Official wording
Reason: The recalled product leaks at the connection site.
Code information: Lot numbers: 80106 and 80106b
Distribution pattern: Distributed to one customer in Michigan.
Derived failure modes
-
Unknown
The recalled product leaks at the connection site.