Recall Z-0279-2023 ยท GES Blade, Scalpel
Southmedic, Inc.
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
| Date | Nov 23, 2022 (initiated Oct 27, 2022) |
| Status | Open, Classified |
| 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. |
| Root 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 | 450 units |
| Distribution | US Nationwide distribution in the state of IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.