FDA recall Z-0279-2023

Southmedic, Inc. · Class II · device

Product

Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

Reason for recall

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.

Distribution

US Nationwide distribution in the state of IL.

Key facts

Status
Ongoing
Initiation date
2022-10-27
Report date
2022-11-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Barrie, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2023