FDA Medical Device Recalls (openFDA)
Circulatory Technology Inc: 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.
- Recall number
- Z-1323-2010
- Recalling firm
- Circulatory Technology Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-06-03
- Posted
- 2010-04-13
- Terminated
- 2010-05-14
- Reason
- 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.
- Root 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
- 144 units
- Distribution
- Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
- Lot, serial or model codes
- Lot Number 9910-18907 (exp. 10/2011)
- 510(k) numbers
- ["K981284"]
- PMA numbers
- not on file
- Product code
- DTN
- Firm FEI
- 1000522036
- Firm city
- Oyster Bay
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28