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Recall Observatory FDA recall evidence

Device product

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

Z-0279-2023

October 27, 2022

Class II

Product summary

Firm
Southmedic, Inc.
Event
Event 91129
Status
Ongoing
Classification
Class II
Quantity
450 units
Official record key
device-enforcement:Z-0279-2023

Official wording

Reason: 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.

Code information: GTIN 620974002628, Lot number: W92761

Distribution pattern: US Nationwide distribution in the state of IL.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    non-sterile product labelled as sterile