Datascope Recalls BEQ-TOP 24500 Adult ECC Custom Tubing Kits
Datascope is recalling four BEQ-TOP 24500 Adult ECC Custom Tubing Kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing 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 life-support device (ECMO) that can cause a drop in blood flow, meeting the criteria for a Severe rating.
Plain-English summary
Datascope Corporation is recalling four units of the BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253. The recall involves specific lots identified as 3000055326 and 3000064943. 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 was initiated because the Better Bladder device included in some of these custom tubing kits may experience seal separation from the housing. This defect can allow air to enter the housing, which may 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 providers and facilities that have received these specific kits should stop using them immediately and contact Datascope Corporation for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
- Manufacturer
- Datascope Corporation
- Affected units
- 4
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 (2)
- Lot 3000055326
- 3000064943
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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