Datascope Corporation recalls Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Recalled Product
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
Hazard / Issue
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
Issued by
FDA
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