FDA-Device2014-05-21Class II
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch flo
Greatbatch Medical
Hazard
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
Sold states
US Nationwide Distribution in the state of UT.
Affected count
6,642 sets (66,420 devices)
Manufactured in
2300 Berkshire Ln N, Minneapolis, MN, United States
Products
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1614-2014Don't want to check this manually?
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