Circulatory Technology Recalls Better-Bladder ECMO Blood Reservoirs
Circulatory Technology Inc is recalling Better-Bladder cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a critical life-support device that can cause a drop in blood flow, meeting the criteria for a Severe rating.
Plain-English summary
Circulatory Technology Inc is recalling 840 units of Better-Bladder cardiopulmonary bypass blood reservoirs, including Models BB14 and BB14NS. These devices are used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits.
The recall was initiated because the devices may collapse during use. This collapse can increase resistance to flow in the venous line and cause a drop in circuit blood flow. The affected units were distributed in 19 states and the District of Columbia.
Healthcare facilities and kit manufacturers should stop using the affected lot numbers and contact the manufacturer for instructions on return or replacement. The recall includes specific lot numbers for both the BB14 and BB14NS models.
The recalled product
- Product
- Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
- Manufacturer
- Circulatory Technology Inc
- Affected units
- 840
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 5290-S19786
- 5290-S19872
- **5290-S19925
- BB14NS Lot Numbers: 17062201
- 17062202
- 17062203
- and **170905
Distribution
Part of a larger recall action
This product is one of 2 recalled by Circulatory Technology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Circulatory Technology Inc
See all →- HighBetter-Bladder ECMO Device May Collapse, Reducing Blood Flow
FDA (Devices) · 2021-06-23
- SevereCirculatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs
FDA (Devices) · 2018-03-07
- LowCirculatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
FDA (Devices) · 2016-10-19
- HighCirculatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak
FDA (Devices) · 2016-09-21
- HighCirculatory Technology Recalls Bigger-Better-Bladder Medical Devices Due to Seal Leak
FDA (Devices) · 2016-07-06