Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling specific custom tubing kits because the Better Bladder device may allow air to enter, 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 six units of the BEQ-T 9410 Lurie Chldns Small 1/4 Custom Tubing Kit, Catalog No. 709000430, Lot 3000060035. The recall involves the Better Bladder device provided as part of these kits.
The recall is due to a potential seal separation from the housing, which may allow air to enter and collapse the balloon. This failure could increase resistance to flow in the venous line and cause a drop in blood flow within the ECMO circuit.
The affected 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. Healthcare facilities should stop using the affected kits and contact Datascope Corporation for instructions on returning the products.
The recalled product
- Product
- BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
- Manufacturer
- Datascope Corporation
- Affected units
- 6
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 3000060035
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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