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U.S. Department of Health and Human Services

Class 2 Device Recall BetterBladder

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  Class 2 Device Recall BetterBladder see related information
Date Initiated by Firm September 22, 2017
Date Posted March 01, 2018
Recall Status1 Terminated 3 on May 20, 2020
Recall Number Z-0817-2018
Recall Event ID 79196
510(K)Number K981284  
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
Product Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Code Information **Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905
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 device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.
FDA Determined
Cause 2		 Process control
Action The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If the pigtail dislodges then return the unit for credit or replacement. The consignees should complete and return the enclosed response form via email to ytamari@cirtec.com as soon as possible.
Quantity in Commerce 840
Distribution **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
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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