Recall Z-0988-2011
Southmedic, Inc. · initiated September 3, 2010
Product
Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, 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.
Codes / lots: Lot numbers: 070610, 82010, 82610, and 91710.
Reason for recall
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0988-2011
- Initiated
- September 3, 2010
- Posted by FDA
- January 31, 2011
- Terminated
- May 18, 2011
- Product code
- GDX – Scalpel, One-Piece
- Quantity
- 1330 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.
- Recalling firm
- Southmedic, Inc., Barrie Canada, Ontario
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0989-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size…Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | 09/03/2010Terminated |
| Z-0990-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size…Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | 09/03/2010Terminated |