Class 2 Device Recall

• Date Initiated by Firm: February 25, 2003
• Date Posted: April 03, 2003
• Recall Status: Terminated on July 07, 2003
• Recall Number: Z-0708-03
• Recall Event ID: 25788
• Product Classification: Strip, Dialysate Ph Indicator - Product Code MNV
• Product: 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.
• Code Information: Finished device lot numbers 502974, 505303, on outside of box. Individual pouches labeled with ''raw'' lot number NH030123-1.
• Recalling Firm/ Manufacturer: Deroyal Surgical -Rose Hill; 100 Rose Hill Industrial Park; Rose Hill VA 24281
• For Additional Information Contact: Sharon Cook; 888-938-7828 Ext. 6157
• Manufacturer Reason for Recall: Non-sterile surgical medical device is labeled as sterile product.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 216 units
• Distribution: Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.