Class 2 Device Recall Bigger BetterBladder

• Date Initiated by Firm: June 03, 2009
• Date Posted: April 13, 2010
• Recall Status: Terminated on May 14, 2010
• Recall Number: Z-1323-2010
• Recall Event ID: 55137
• 510(K)Number: K981284
• Product Classification: reservoir, blood, cardiopulmonary - Product Code DTN
• Product: The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- Manufactured for: Circulatory Technology Inc., 21 Singworth Street, Oyster Bay, 11771 (516) 624-2424 --- 510 (k) 981284.
• Code Information: Lot Number 9910-18907 (exp. 10/2011)
• Recalling Firm/ Manufacturer: Circulatory Technology Inc; 21 Singworth Street; Oyster Bay NY 11771-3703
• For Additional Information Contact: Mr. Yehuda Tamari; 516-624-2424
• Manufacturer Reason for Recall: During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.
• FDA Determined Cause: Process control
• Action: The firm, Circulatory Technology, Inc., sent an email to Bigger Better-Bladder end user accounts on 6/03/09 and again on 6/13/09. The firm followed up with phone calls to the user customers. The emails and calls discussed the product, problem and the actions to be taken by the customers. The customers are ask to examine their stock of Bigger Better-Bladder for the affected units and then visually examine each unit to assure that adhesive has been applied and when the tube is bent away from cap, no separation is visible along the joint between the two according to the picture provided. The customers should return for full credit or a replacement of any product that has a separation of the seal. Please feel free to contact Mr. Yehuda Tamari at 516-624-2424 with any questions.
• Quantity in Commerce: 144 units
• Distribution: Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
• 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