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Recall Observatory FDA recall evidence

Device product

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.

Z-0057-2017

July 01, 2016

Class III

Product summary

Firm
Circulatory Technology Inc
Event
Event 74614
Status
Terminated
Classification
Class III
Quantity
958 units
Official record key
device-enforcement:Z-0057-2017

Official wording

Reason: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

Code information: Lot Numbers: R19229, 015323, 014882, 014602 & 014601

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.