PlainRecalls
FDA Devices Moderate 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 provi

Reported: September 21, 2016 Initiated: July 1, 2016 #Z-2832-2016

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.

Details

Units Affected
20 units
Distribution
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Location
Oyster Bay, NY

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Circulatory Technology Inc. Units affected: 20 units.
Why was this product recalled? ▼
The seal between the balloon and the housing may leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2832-2016.

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