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.
This recall has been terminated (originally issued April 3, 2003).
- Recall Initiated
- February 25, 2003
- Posted
- April 3, 2003
- Terminated
- July 7, 2003
- Recall Number
- Z-0708-03
- Quantity
- 216 units
- Firm Location
- Rose Hill, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Non-sterile surgical medical device is labeled as sterile product.
Distribution
Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
Lot / Code Info
Finished device lot numbers 502974, 505303, on outside of box. Individual pouches labeled with ''raw'' lot number NH030123-1.
Root Cause
Other
Action Taken
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.