Datascope recalls BEQ-TOP 5210 ECC Set custom tubing kits
Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.
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 can cause a drop in ECMO circuit blood flow, posing a significant risk of injury.
Plain-English summary
Datascope Corporation is recalling 18 units of the BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01. The affected lots are 3000061303 and 3000056130. 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 in the Better Bladder device included in the kits. Seal separation from the housing may allow air to enter the housing, which can cause the balloon to collapse. This collapse may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Healthcare facilities and consumers should stop using the affected products and contact Datascope Corporation for instructions on how to return or replace the units.
The recalled product
- Product
- BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
- Manufacturer
- Datascope Corporation
- Affected units
- 18
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 3000061303
- 3000056130
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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