FDA-Device2017-09-13Class II
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Cardinal Health 200, LLC
Hazard
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Sold states
Worldwide Distribution - US (Nationwide) and Internationally to Canada
Affected count
184,102 kits
Manufactured in
1500 S Waukegan Rd, N/A, Waukegan, IL, United States
Products
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3107-2017Don't want to check this manually?
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