Datascope Recalls Better Bladder Custom Tubing Kits Due to Seal Separation
Datascope Corporation is recalling 10 units of the BEQ-T 25501 Better Bladder Pack, Custom Tubing Kit. A seal defect may allow air entry, causing balloon collapse and reduced 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. The hazard involves a drop in ECMO circuit blood flow, which is a significant injury risk for patients on life-support systems, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Datascope Corporation is recalling 10 units of the BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370. The affected units are identified by Lot 3000060037. 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 a seal on the Better Bladder device may separate from the housing. This separation 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 (extracorporeal membrane oxygenation) circuit.
Healthcare facilities and accounts that received these products should stop using the affected tubing kits immediately. Users should contact Datascope Corporation for further instructions regarding the return or replacement of the recalled units.
The recalled product
- Product
- BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
- Manufacturer
- Datascope Corporation
- Affected units
- 10
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 3000060037
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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