Events

Recall of 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.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deroyal Surgical -Rose Hill.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25788
  • Event Risk Class
    Class 2
  • Event Number
    Z-0708-03
  • Event Initiated Date
    2003-02-25
  • Event Date Posted
    2003-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26478
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Strip, Dialysate Ph Indicator - Product Code MNV
  • Reason
    Non-sterile surgical medical device is labeled as sterile product.
  • 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.

Device

DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more...
  • Model / Serial
    Finished device lot numbers 502974, 505303, on outside of box. Individual pouches labeled with ''raw'' lot number NH030123-1.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sold to distributors and direct accounts in PA, TX, WA, AR, HI, CA and TN.
  • Product Description
    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.
  • Manufacturer
    Deroyal Surgical -Rose Hill

Manufacturer

Deroyal Surgical -Rose Hill
  • Manufacturer Address
    Deroyal Surgical -Rose Hill, 100 Rose Hill Industrial Park, Rose Hill VA 24281
  • Source
    USFDA