Device product
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Z-0279-2023
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
non-sterile product labelled as sterile