Datascope Custom Tubing Kit Recall Due to Seal Separation
Datascope is recalling 9 custom tubing kits because seal separation 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. 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 9 units of the BEQ-TOP 27610 ECC PACK 3/8 Custom Tubing Kit, Catalog No. 701065622. The affected lots are 3000058734 and 3000063711. 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. 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 in the ECMO circuit.
Healthcare facilities and consumers who have these specific custom tubing kits should stop using them and contact Datascope Corporation for instructions on how to return the product.
The recalled product
- Product
- BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
- Manufacturer
- Datascope Corporation
- Affected units
- 9
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 3000058734
- 3000063711
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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