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U.S. Department of Health and Human Services

Class 3 Device Recall Better Baldder

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  Class 3 Device Recall Better Baldder see related information
Date Initiated by Firm July 01, 2016
Date Posted October 07, 2016
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-0057-2017
Recall Event ID 74614
510(K)Number K981284  
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
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.
Code Information Lot Numbers: R19229, 015323, 014882, 014602 & 014601
Recalling Firm/
Manufacturer		 Circulatory Technology Inc
21 Singworth St
Oyster Bay NY 11771-3703
For Additional Information Contact Yehuda Tamari
516-624-2424
Manufacturer Reason
for Recall		 Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
FDA Determined
Cause 2		 Use error
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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTN and Original Applicant = CIRCULATORY TECHNOLOGY, INC.
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