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U.S. Department of Health and Human Services

Class 2 Device Recall Southmedic/Personna Safety Scalpel

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  Class 2 Device Recall Southmedic/Personna Safety Scalpel see related information
Date Initiated by Firm September 03, 2010
Date Posted January 31, 2011
Recall Status1 Terminated 3 on May 18, 2011
Recall Number Z-0990-2011
Recall Event ID 56963
Product Classification One-Piece Scalpel - Product Code GDX
Product Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.
Code Information Lot numbers: 070910, 081610, 90110, 91410, and 93010.
Recalling Firm/
Southmedic, Inc.
50 Alliance Blvd.
Barrie Canada Ontario
For Additional Information Contact Marc Pauze
800-463-7146 Ext. 299
Manufacturer Reason
for Recall
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
FDA Determined
Cause 2
Packaging process control
Action On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.
Quantity in Commerce 1330 cases all products
Distribution Worldwide Distribution -- USA, including states of TX, MO, NJ, LA, IL, NY, KY, PA, VA, WA, CA, MA, MD, IN, NV, TN, NC, AZ, IA, WI, UT, NE, GA, FL, MN, ME, OH, SD, and KS and countries of Australia and Canada.
Total Product Life Cycle TPLC Device Report

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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.