Z-0279-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- October 27, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 units
Product Description
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 Pattern
US Nationwide distribution in the state of IL.
Code Information
GTIN 620974002628, Lot number: W92761