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.
FDA Recall Z-2832-2016 · Posted None
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Recalling FirmCirculatory Technology Inc
Recall StatusTerminated
Product CodeDTN
Date Initiated2016-07-01
Date Terminated2018-06-14
Product Quantity20 units
Reason for Recall
The seal between the balloon and the housing may leak.
Firm Action
The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to [email protected].
Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.
Root Cause
Device Design
Distribution Pattern
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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