Circulatory Technology Inc. Recall 88000
Description: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Circulatory Technology Inc. Recall 88000 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1862-2021 |
| Event ID | 88000 |
| Event Description | The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX. |
| Quantity | 147 units |
| Recall 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. |
| Device Classification | 20210623 |
| Device Code Info | Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021 |
| Center Classification Date | 20210615 |
| Recall Initiation Date | 20210427 |
| Recalling Firm | Circulatory Technology Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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