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U.S. Department of Health and Human Services

Class 2 Device Recall BBB3872

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 Class 2 Device Recall BBB3872see related information
Date Initiated by FirmJuly 01, 2016
Create DateSeptember 15, 2016
Recall Status1 Terminated 3 on June 14, 2018
Recall NumberZ-2832-2016
Recall Event ID 74991
510(K)NumberK981284 
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
ProductThe Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Code Information Lot # 014648 USE BY: 09/01/2018
Recalling Firm/
Manufacturer		 Circulatory Technology Inc
21 Singworth St
Oyster Bay NY 11771-3703
For Additional Information ContactYehuda Tamari
516-624-2424
Manufacturer Reason
for Recall		The seal between the balloon and the housing may leak.
FDA Determined
Cause 2		Device Design
ActionThe firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST.
Quantity in Commerce20 units
DistributionUS Distribution to states of: LA, MI, NY, OH, OR & TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTN
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