FDA Recall
Terminated
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
Recall: Z-0708-03
·
Initiated February 25, 2003
Recall
- Recall Number
- Z-0708-03
- Event Number
- 25788
- FEI Number
- 1046367
- Product Code
- MNV
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 25, 2003
- Posted
- April 3, 2003
- Terminated
- July 7, 2003
- Address
- Deroyal Surgical Rose Hill 100 Rose Hill Industrial Park, Rose Hill, VA, 24281
Description
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
Reason
Non-sterile surgical medical device is labeled as sterile product.
Action
Recalling firm notified consignees by certified mail 2/25/03 and advised to immediately cease using or distributing product. Distributors were requested to further notify their consignees or provide customer contacts. Consignees requested to return response form for replacement product.
Distribution
Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
Quantity
216 units