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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DTN
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