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FDA (Device enforcement)Recalled 2022-10-27class ii

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

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.

Details from the source

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. Quantity: 450 units Lot/code info: GTIN 620974002628, Lot number: W92761

UPC codes

620974002628

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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