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Open, Classified

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

FDA Recall Z-0279-2023 · Posted 2022-11-23

Recalling FirmSouthmedic, Inc.
Recall StatusOpen, Classified
Product CodeGES
Date Initiated2022-10-27
Product Quantity450 units

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.

Firm Action

Southmedic sent and URGENT: MEDICAL DEVICE RECALL notice its consignees on 10/28/2022 by email. The notice explained the issue and requested the product be destroyed. The response forms indicate that the direct consignee notify its customers

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the state of IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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