Datascope recalls custom pediatric ECMO tubing kits due to seal defect
Datascope is recalling two custom pediatric ECMO tubing kits because a seal defect may allow air to enter the device, potentially 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 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 two units of the BEQ-TOP 50903 Custom ECC Pack-Pediatric Custom Tubing Kit, Catalog No. 709000078, Lot 3000063290. The recall involves the Better Bladder device included in these custom kits.
The recall is due to a potential seal separation from the housing. This defect may allow air to enter the housing and collapse the balloon. Such a failure could increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
The affected units were distributed to accounts in Alabama, Arkansas, California, the District of Columbia, Florida, Illinois, Louisiana, Missouri, North Carolina, Pennsylvania, South Carolina, Texas, and Washington. Users should contact Datascope Corporation for instructions on how to address the defect.
The recalled product
- Product
- BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
- Manufacturer
- Datascope Corporation
- Affected units
- 2
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 3000063290
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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