Datascope Recalls Custom Tubing Kits Due to Seal Separation Risk
Datascope Corporation is recalling four custom tubing kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.
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, which aligns with the High severity criteria.
Plain-English summary
Datascope Corporation is recalling four units of the BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit (Catalog No. 701050966, Lot 3000063810). The recall is due to a defect in the Better Bladder device included in the kits, where seal separation from the housing may allow air to enter. This air entry can cause the balloon to collapse, which may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
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. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare providers and facilities should stop using the affected custom tubing kits immediately. Users should contact Datascope Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
- 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 3000063810
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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