The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
FDA Recall Z-0057-2017 · Posted 2016-10-07
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Recalling FirmCirculatory Technology Inc
Recall StatusTerminated
Product CodeDTN
Date Initiated2016-07-01
Date Terminated2017-04-14
Product Quantity958 units
Reason for Recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Firm Action
The firm, Circulatory Technology Inc., sent an "Urgent: Device Recall" letter dated July 1, 2016 and response forms to their customers via email. The letter described the product, problem and actions to be taken. The letter instructed customers to immediately inspect their inventory visually for units with wrinkled or twisted balloons and quarantine. Customers were also advised to complete and return the response form via email to [email protected].
Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.
Root Cause
Use error
Distribution Pattern
US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
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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