Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
FDA device recall Z-0279-2023 · posted 2022-11-23 · Open, Classified
Recall details
- Recalling firm
- Southmedic, Inc.
- 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.
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GES
- Quantity affected
- 450 units
- Distribution
- US Nationwide distribution in the state of IL.
- Date initiated
- 2022-10-27
- Date posted
- 2022-11-23
- Location
- Barrie, Canada
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