FDA Enforcement
Class II
Terminated
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.
Recall: Z-2832-2016
·
Reported September 21, 2016
Enforcement
- Recall Number
- Z-2832-2016
- Event ID
- 74991
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Circulatory Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 21, 2016
- Initiation Date
- July 1, 2016
- Classification Date
- September 15, 2016
- Termination Date
- June 14, 2018
- Address
- 21 Singworth St, N/A, Oyster Bay, NY, 11771-3703, United States
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
The seal between the balloon and the housing may leak.
Code Info
Lot # 014648 USE BY: 09/01/2018
Distribution
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Quantity
20 units