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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.

FDA Recall Z-0708-03 · Posted 2003-04-03

Recalling FirmDeroyal Surgical -Rose Hill
Recall StatusTerminated
Product CodeMNV
Date Initiated2003-02-25
Date Terminated2003-07-07
Product Quantity216 units

Reason for Recall

Non-sterile surgical medical device is labeled as sterile product.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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