Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Steri

FDA device recall Z-0989-2011 · posted 2011-01-31 · Terminated

Recall details

Recalling firm

Southmedic, Inc.

Reason for recall

Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.

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.

Root cause

Packaging process control

Status

Terminated

Product code

GDX

Quantity affected

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

Date initiated

2010-09-03

Date posted

2011-01-31

Date terminated

2011-05-18

Location

Barrie Canada, Ontario