Recall Z-1544-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where
| Date | May 2, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing. |
| Root cause | Reprocessing Controls |
| Action | Stryker sent an Urgent Device Corrections letters dated April 18, 2014 to all US customers via certified mail. Stryker Sales representative and Stryker international distributors were notified with the letter and response card by e-mail. International sites are responsible for notifying customers. The letter identified the affected product, problem, potential hazards and actions to be taken. Customers were instructed to complete and sign the enclosed Acknowledgement of Receipt form and scan and e-mail to endorecall@stryker.com. For questions call 1-800-624-4422 option 3 or via email at en |
| Quantity | 2591 trays |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935237 | STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Stryker Endoscopy, Mar 21, 1994 |