FDA-Device2016-07-06Class II
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Circulatory Technology Inc
Hazard
The seal between the balloon and the housing may leak.
Sold states
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
Affected count
72 units
Manufactured in
21 Singworth St, Oyster Bay, NY, United States
Products
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2016Don't want to check this manually?
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