Events

Recall of Device Recall Stryker Scope Warmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

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
    56110
  • Event Risk Class
    Class 2
  • Event Number
    Z-2622-2010
  • Event Initiated Date
    2010-06-21
  • Event Date Posted
    2010-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92686
  • 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
    Laparoscope, general; plastic surgery - Product Code GCJ
  • Reason
    Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
  • Action
    Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.

Device

Device Recall Stryker Scope Warmer
  • Model / Serial
    Model number 502-360-000, all serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
  • Product Description
    Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA