Recall Z-2832-2016— Circulatory Technology Inc
Class II · Terminated
Class II FDA medical device recall by Circulatory Technology Inc, initiated 2016-07-01, terminated 2018-06-14. It names one FDA 510(k) clearance: K981284. Product: 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..
- Recalling firm
- Circulatory Technology Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-01
- Terminated
- 2018-06-14
- Firm location
- Oyster Bay, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.