Z-2832-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- July 1, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Reason for Recall
The seal between the balloon and the housing may leak.
Distribution Pattern
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Code Information
Lot # 014648 USE BY: 09/01/2018