Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation
Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO 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 medical device defect that could cause a drop in ECMO circuit blood flow, which is a significant injury risk.
Plain-English summary
Datascope Corporation is recalling the BEQ-T 25502 1/4 Better Bladder Custom Tubing Kit, Catalog No. 709000434. The recall involves 40 units from Lot 3000062029. These devices 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 seal separation from the housing. This defect may allow air to enter the housing and cause the balloon to collapse. If the balloon collapses, it may increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
Healthcare facilities and consumers who have this specific product should stop using it immediately and contact Datascope Corporation for instructions on how to return the device or obtain a replacement.
The recalled product
- Product
- BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
- Manufacturer
- Datascope Corporation
- Affected units
- 40
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 3000062029
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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