FDA-Device2018-05-16Class II
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Datascope Corporation
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.
Sold states
Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.
Affected count
4
Manufactured in
15 Law Dr, N/A, Fairfield, NJ, United States
Products
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1726-2018Don't want to check this manually?
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