FDA-Device2018-05-16Class II
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
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
11
Manufactured in
15 Law Dr, N/A, Fairfield, NJ, United States
Products
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2018Don't want to check this manually?
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