Recall Z-0989-2011 ยท GDX Scalpel, One-Piece
Southmedic, Inc.
Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, 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.
| Date | Jan 31, 2011 (initiated Sep 3, 2010) |
| Status | Terminated |
| Reason | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| Root cause | 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 Confirmati |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.