Datascope Corporation recalls ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Cat
Recalled Product
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
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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