Recall Z-2050-2016 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Circulatory Technology Inc
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
| Date | Mar 3, 2016 |
| Status | Terminated |
| Reason | The seal between the balloon and the housing may leak. |
| Root cause | Device Design |
| Action | Circulatory Technology Inc. sent an Urgent Product Recall notices dated March 3, 2016, to their customers via email. Circulatory Technology Inc. has identified this action as a voluntary recall, however they did not withdraw the product from the market. Instead, Circulatory Technology Inc. has advised customers to check the integrity of the seal between both the inlet and outlet tube and the housing as per the Instructions For Use. In addition, for this lot, Circulatory Technology Inc. recommends that you bend the inlet as well as the outlet tube away from the housing before conducting the |
| Quantity | 72 units |
| Distribution | US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc., Aug 12, 1998 |