Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs
Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 410 units of Bigger Better-Bladder cardiopulmonary bypass blood reservoirs, specifically models BBB38 and BBB38NS. The recall was expanded to include these specific models and lot numbers: BBB38 (Lot 5300-S19813) and BBB38NS (Lots 1707-1 and 170903).
The devices are used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. The recall is being issued because the reservoirs 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 (AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA) and the District of Columbia. Healthcare facilities and kit manufacturers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- **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)
- Manufacturer
- Circulatory Technology Inc
- Affected units
- 410
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 (4)
- **Recall expanded to add these models: BBB38
- Lot Number: 5300-S19813
- BBB38NS
- Lot Number: 1707-1 and 170903
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
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- SevereCirculatory Technology Recalls Better-Bladder ECMO Blood Reservoirs
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- LowCirculatory Technology Recalls Better-Bladder Devices Due to Cosmetic Defects
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- HighCirculatory Technology Recalls Bigger-Better-Bladder 2 Devices Due to Seal Leak
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- HighCirculatory Technology Recalls Bigger-Better-Bladder Medical Devices Due to Seal Leak
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