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Datascope Corporation recalls ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Recalled May 16, 2018 · FDA recall Z-1727-2018 · Datascope
Hazard
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. · FDA Class II
Units
4
Sold at
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
Description
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.
Product
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Manufacturer(s)
Datascope Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →