Reported Sep 21, 2016 · Terminated
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure…
Circulatory Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Circulatory Technology Inc · 21 Singworth St · Oyster Bay, NY · 11771-3703
Is this the product you have?
- 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.
- Lot codes and dates
- Lot # 014648
- USE BY09/01/2018
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
The seal between the balloon and the housing may leak.
This product could cause temporary or reversible health problems — stop using it.
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