Recall Z-1171-2018 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Circulatory Technology Inc
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
| Date | Mar 1, 2018 (initiated Sep 22, 2017) |
| Status | Terminated |
| Reason | The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow. |
| Root cause | Process control |
| Action | The firm is requesting that consignees immediately inspect inventory, and quarantine all units having the aforementioned lots. These units must be returned to CTI. CTI will provide UPS shipping labels for returning the units and will provide replacements or credit for the returned units. Should the inventory consist of only the affected lots then, until the consignee receives replacement BB14s from an unaffected lot, the firm recommends using the BB14 from the affected lots only if, prior to its use, they pull on the pigtail of the Better-Bladder to test its bond integrity prior to its use. If |
| Quantity | 410 |
| Distribution | **Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc., Aug 12, 1998 |