Recall Z-0279-2023— Southmedic, Inc.
Class II · Ongoing
Class II FDA medical device recall by Southmedic, Inc., initiated 2022-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO. 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..
- Recalling firm
- Southmedic, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-27
- Firm location
- Barrie, N/A, Canada
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.