DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staple
FDA device recall Z-0708-03 · posted 2003-04-03 · Terminated
Recall details
- Recalling firm
- Deroyal Surgical -Rose Hill
- Reason for recall
- Non-sterile surgical medical device is labeled as sterile product.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNV
- Quantity affected
- 216 units
- Distribution
- Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
- Date initiated
- 2003-02-25
- Date posted
- 2003-04-03
- Date terminated
- 2003-07-07
- Location
- Rose Hill, VA
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