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.
- Company
- Circulatory Technology Inc
- Recall Initiated
- June 3, 2009
- Posted
- April 13, 2010
- Terminated
- May 14, 2010
- Recall Number
- Z-1323-2010
- Quantity
- 144 units
- Firm Location
- Oyster Bay, NY
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.
Distribution
Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
Lot / Code Info
Lot Number 9910-18907 (exp. 10/2011)
Root Cause
Process control
Action Taken
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.