medical Class II Updated 2018-05-16

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

Affected States: AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, WA
Lot/Code Info: Lot 3000060036
View official government recall

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