FDA-Device2021-08-18Class II
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Cordis Corporation
Hazard
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Affected count
8 units
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2021Don't want to check this manually?
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