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.
- Company
- Circulatory Technology Inc
- Recall Initiated
- July 1, 2016
- Posted
- October 7, 2016
- Terminated
- April 14, 2017
- Recall Number
- Z-0057-2017
- Quantity
- 958 units
- Firm Location
- Oyster Bay, NY
Reason for Recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
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.
Lot / Code Info
Lot Numbers: R19229, 015323, 014882, 014602 & 014601
Root Cause
Use error
Action Taken
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 ytamari@cirtec.com. Customers with questions are asked to contact Yehuda Tamari at (516) 624-2424, Monday to Friday, 9:00 AM - 7:00 PM, EST.