Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE recalled over sterility concerns

Recall date

October 27, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0279-2023

FDA classification

Class II

Brand / firm

Southmedic, Inc.

Sold / distributed

US Nationwide distribution in the state of IL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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