The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8… recallZ-1323-2010 · Circulatory Technology Inc · initiated Jun 3, 2009
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Circulatory Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1323-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 3, 2009
- Posted by the FDA
- Apr 13, 2010
- Recalling firm
- Circulatory Technology Inc
- Quantity
- 144 units
- Product code
- DTN
- FDA submissions
- K981284
- Distribution
- Arizona, Arkansas, California, Florida, Indiana, Iowa, Maine, Michigan, Nebraska, New York, North Carolina, Pennsylvania, Ohio, Texas, Utah, Washington DC, and Germany.
Product description
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 (models, lots, serial numbers)
Lot Number 9910-18907 (exp. 10/2011)
Other devices under the same FDA submission
2 devices cleared under K981284 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Better-Bladder BB14Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS1 recall5 reports
- Bigger Better-Bladder BBB38Circulatory Technology Inc · RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page