Recall Z-1862-2021 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Circulatory Technology Inc.
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
| Date | Apr 27, 2021 |
| Status | Open, Classified |
| 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 | On April 27, 2021, CTI issued an Urgent Medical Device Removal notice to customers via email and phone, notifying them three better bladder BB14 units were found to have the pigtails dislodge from the housing. We are requesting that you immediately inspect your 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. Replacement BB14 from an unaffected lot will be available for shipping early next week. However, if you n |
| Quantity | 147 units |
| Distribution | US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981284 | BETTER-BLADDER (BB) Circulatory Technology, Inc., Aug 12, 1998 |