Recall Z-1323-2010 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
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.
| Date | Apr 13, 2010 (initiated Jun 3, 2009) |
| Status | Terminated |
| 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 c |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc., Aug 12, 1998 |