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.
Reported: October 19, 2016 Initiated: July 1, 2016 #Z-0057-2017
Product Description
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.
Reason for Recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Details
- Recalling Firm
- Circulatory Technology Inc
- Units Affected
- 958 units
- Distribution
- 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.
- Location
- Oyster Bay, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Circulatory Technology Inc. Units affected: 958 units.
Why was this product recalled? ▼
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Low. Recall number: Z-0057-2017.
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