PlainRecordsFDA · Medical device recall
DeRoyal''s SurgiMate (tm) Skin Stapler…
- Date posted by the FDA
- April 3, 2003
- Status
- Terminated
- Filed by
- Deroyal Surgical -Rose Hill
- 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.
- Reason
- Non-sterile surgical medical device is labeled as sterile product.
- Distribution pattern
- Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
- Quantity
- 216 units
- Codes and lots
- Finished device lot numbers 502974, 505303, on outside of box. Individual pouches labeled with ''raw'' lot number NH030123-1.
- Recall started
- Feb. 25, 2003
- Device type
- Strip, Dialysate Ph Indicator
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0708-03
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-0708-03. The agency record governs; check it and the company before acting.