12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments
FDA device recall Z-1544-2014 · posted 2014-05-02 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
- Action taken
- 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 endorecall@stryker.com.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2591 trays
- Distribution
- Worldwide distribution
- Date initiated
- 2014-04-16
- Date posted
- 2014-05-02
- Date terminated
- 2014-08-18
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES (K935237) | Stryker Endoscopy | 1994-03-21 |