FDA-Device2022-11-09Class II
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Sold states
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Affected count
95 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0155-2023Don't want to check this manually?
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