Device product
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Z-2050-2016
Product summary
- Event
- Event 73608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-2050-2016
Official wording
Reason: The seal between the balloon and the housing may leak.
Code information: Lot # 014603 USE BY: 9/2018
Distribution pattern: US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Derived failure modes
-
Unknown
The seal between the balloon and the housing may leak.