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U.S. Department of Health and Human Services

Class 2 Device Recall BBB38

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  Class 2 Device Recall BBB38 see related information
Date Initiated by Firm March 03, 2016
Create Date June 27, 2016
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-2050-2016
Recall Event ID 73608
510(K)Number K981284  
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
Product Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Code Information Lot # 014603 USE BY: 9/2018
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		 The seal between the balloon and the housing may leak.
FDA Determined
Cause 2		 Device Design
Action Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the leak test. There should be no visible separation between the tubing and the housing. Customers with questions can call 516-624-2424.
Quantity in Commerce 72 units
Distribution US Distribution to the states of: CA, IN, MI, NY, PA, 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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