Datascope recalls custom tubing kits due to seal separation risk
Datascope is recalling four custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could cause a drop in ECMO circuit blood flow, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling four units of the ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit (Catalog No. 701055604, Lot 3000061303). The recall involves the Better Bladder device included in these 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, which could increase resistance to flow in the venous line and cause a drop in blood flow in 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. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
- Manufacturer
- Datascope Corporation
- Affected units
- 4
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 3000061303
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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