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.
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. Quantity: 450 units Lot/code info: GTIN 620974002628, Lot number: W92761
620974002628
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.