Date Initiated by Firm |
October 27, 2022 |
Date Posted |
November 23, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0279-2023 |
Recall Event ID |
91129 |
Product Classification |
Blade, scalpel - Product Code GES
|
Product |
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO |
Code Information |
GTIN 620974002628, Lot number: W92761 |
Recalling Firm/ Manufacturer |
Southmedic, Inc. 50 Alliance Blvd Barrie Canada
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
450 units |
Distribution |
US Nationwide distribution in the state of IL. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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