Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
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, posing a significant risk of serious injury.
Plain-English summary
Datascope Corporation is recalling the BEQ-TOP 22300 Custom Tubing Kit, Catalog No. 701049504. The recall involves three units from lots 3000057378 and 3000061216. 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 defect where the seal may separate from the housing of the Better Bladder device included in the kit. This separation allows air to enter the housing, which can 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 accounts that received these specific lots should stop using the affected tubing kits and contact Datascope Corporation for instructions on how to return or dispose of the products.
The recalled product
- Product
- BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
- 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 (2)
- Lot 3000057378
- 3000061216
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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