FDA Enforcement
Class II
Terminated
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Recall: Z-2050-2016
·
Reported July 6, 2016
Enforcement
- Recall Number
- Z-2050-2016
- Event ID
- 73608
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Circulatory Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 6, 2016
- Initiation Date
- March 3, 2016
- Classification Date
- June 27, 2016
- Termination Date
- April 20, 2017
- Address
- 21 Singworth St, Oyster Bay, NY, 11771-3703, United States
Description
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Reason
The seal between the balloon and the housing may leak.
Code Info
Lot # 014603 USE BY: 9/2018
Distribution
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Quantity
72 units