Stryker

Cleaning and Sterilization Guides

Shaver Handpiece Sterilization Tray 272-700-000 Urgent Device Correction May 2014

Alert

STERRAD 100S parameters incomplete

2 Pages

5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www... ryker... m Endoscopy Urgent: Device Correction Date: May 23, 2014 Attention: Risk Managers, Sterile Processing Department <Customer Name> <Customer Address> <Customer City, State, Zip> Product: Shaver Handpiece Sterilization Tray... art Number 272-700-000 Product Issue: STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing... otential Hazards: Although, to date there have been no reported events of infection to Stryker as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection... ction Required: The STERRAD 100S sterilization method has been removed from the reprocessing guide (P10299 Revision B) as a sterilization option for the TPS Small Joint Shaver... ecipients of this letter are confirmed to have received shipments of at least one Shaver Handpiece Sterilization Tray... lease: 1... iscard any old Instructions for Use for your Shaver Handpiece Sterilization Tray(s)... ownload the new Reprocessing Guide Part Number P10299 Revision B from the URL link below: www... ryker... m/shavertray 3... omplete and sign the enclosed “Acknowledgement of Receipt” form and scan and email to endorecall@stryker... m... We apologize for any inconvenience this action may cause... s we strive to deliver products that meet your expectations for quality and reliability, please do not hesitate to contact us, in case you have any further questions at 408-855-6238 or via email at endorecall@stryker... m... incerely, Regulatory Affairs Director Stryker Endoscopy ` Health care professionals and consumers may report adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone... nline: www... a... v/MedWatch/report... m Mail: Use postage paid FDA form 3500 available at www... a... v/MedWatch/getforms... m and mail to MedWatch, 5600 Fishers La ne, Rockville, MD 208529787 Phone: 1-800-FDA-1088 Fax: 1-800-FDA-0178 1|2 Endoscopy Shaver Handpiece Sterilization Tray Acknowledgement of Receipt Part Number: 272-700-000 Shaver Handpiece Sterilization Tray The acknowledgement card below serves as a record of your receipt of the updated Reprocessing Guide Part Number P10299 Revision B from the URL link below: www... ryker... m/shavertray Please complete the required information below... pproval of the form below indicates that either you have read and understand the Reprocessing Parameters per Reprocessing Guide P10299 Revision B for the Shaver Handpiece Sterilization Tray or the Shaver Handpiece Sterilization Tray is no longer in service at your facility... lease update customer address information below if necessary... haver Handpiece Sterilization Tray Acknowledgement Receipt From: <Customer Name> <Customer Address> <Customer City, State, Zip> Account: <Customer Account Number> CUSTOMER TO COMPLETE INFORMATION BELOW: Printed Name: Title Of Responsible Person: Signature: Date: Complete and sign and scan and email to endorecall@stryker... m... 2|2 `
File Type: PDF
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File Name: shaver_handpiece_sterilization_tray_272-700-000_urg.pdf
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