Recall Z-2832-2016 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Circulatory Technology Inc
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short
| Date | Jul 1, 2016 |
| Status | Terminated |
| Reason | The seal between the balloon and the housing may leak. |
| Root cause | Device Design |
| Action | The firm, Circulatory Technology Inc., sent an amended "Urgent: Expanded Device Recall" letter dated July 1, 2016, and response form to their customers via email. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect their inventory, quarantine and prepare to ship the product back to Circulatory Technology Inc. Customers were also instructed to complete and return the response form via email to ytamari@cirtec.com. Customers with questions can call 516-624-2424, Monday through Friday 9:00 AM - 7:00 PM, EST. |
| Quantity | 20 units |
| Distribution | US Distribution to states of: LA, MI, NY, OH, OR & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc., Aug 12, 1998 |