Class 2 Device Recall Southmedic

• Date Initiated by Firm: October 27, 2022
• Date Posted: November 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0279-2023
• Recall Event ID: 91129
• Product Classification: Blade, scalpel - Product Code GES
• Product: Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
• Code Information: GTIN 620974002628, Lot number: W92761
• FEI Number: 3001717360
• Recalling Firm/ Manufacturer: Southmedic, Inc.; 50 Alliance Blvd; Barrie Canada
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Southmedic sent and URGENT: MEDICAL DEVICE RECALL notice its consignees on 10/28/2022 by email. The notice explained the issue and requested the product be destroyed. The response forms indicate that the direct consignee notify its customers
• Quantity in Commerce: 450 units
• Distribution: US Nationwide distribution in the state of IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.