FDA-Device2023-01-18Class II
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Integra LifeSciences Corp.
Hazard
Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.
Affected count
168 US; 3 OUS
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2023Don't want to check this manually?
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