FDA-Device2022-11-30Class II
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Southmedic, Inc.
Hazard
Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
Sold states
US Nationwide distribution in the state of IL.
Affected count
450 units
Manufactured in
50 Alliance Blvd, N/A, Barrie, N/A, Canada
Products
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief