Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO 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 agency classified this as a Class II recall. The hazard involves a drop in ECMO circuit blood flow, which is a significant injury risk for patients on life support, fitting the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Datascope Corporation is recalling the BEQ-TOP 33500 3/8" ECC PACK (Catalog No. 701053752), which includes the Better Bladder device. The recall involves 3 units of Lot 3000056255. These products were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington.
The recall is due to a potential defect where seal separation from the housing may allow air to enter the housing and collapse the balloon. This issue may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Healthcare facilities and consumers who have this product should stop using it and contact Datascope Corporation for further instructions.
The recalled product
- Product
- BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
- Manufacturer
- Datascope Corporation
- Affected units
- 3
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 (1)
- Lot 3000056255
Distribution
Part of a larger recall action
This product is one of 28 recalled by Datascope Corporation 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.
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