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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 25, 2003
Date Posted April 03, 2003
Recall Status1 Terminated 3 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 2
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.
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