FDA-Device2025-01-01Class II
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Sold states
US Nationwide. Canada.
Affected count
36 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2025Don't want to check this manually?
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