FDA-Device2024-12-11Class II
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Sold states
US Nationwide distribution.
Affected count
336 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2025Don't want to check this manually?
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