Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
This recall is currently active, issued November 23, 2022. It was issued by Southmedic, Inc..
- Company
- Southmedic, Inc.
- Recall Initiated
- October 27, 2022
- Posted
- November 23, 2022
- Recall Number
- Z-0279-2023
- Quantity
- 450 units
- Firm Location
- Barrie Canada
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
GTIN 620974002628, Lot number: W92761
Root Cause
Under Investigation by firm
Action Taken
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