Southmedic Safety Cartridge with Southmedic Plus recall: Sterility Concern
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Why was Southmedic Safety Cartridge with Southmedic Plus recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 620974002628, Lot number: W92761
- Product
- Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
- Recalling firm
- Southmedic, Inc.
- Quantity
- 450 units
- Distribution
- US Nationwide distribution in the state of IL.
- Recall date
- November 30, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)