FDAFDA · Food and drugs·Recall number Z-2832-2016
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.
Published September 21, 2016 · Recall initiated: July 1, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The seal between the balloon and the housing may leak.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Circulatory Technology Inc
- Distributor
- US Distribution to states of: LA, MI, NY, OH, OR & TX.
- Lot
- Lot # 014648 USE BY: 09/01/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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