FDA-Device2024-04-24Class II
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20
Cook Incorporated
Hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Sold states
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Affected count
5,998 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2024Don't want to check this manually?
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