BEUDAMED
    FDA Enforcement Class II Ongoing

    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN; 9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE; 10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED; 11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK; 12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE; 13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD; 14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN; 15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE; 16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED; 17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK; 18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE; 19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD; 20. CD5-61B-GREEN, GENESIS LG NARROW 6" PERF BOTTOM GREEN; 21. CD5-61B-PURPLE, GENESIS LG NARROW 6" PERF BOTTOM PURPLE; 22. CD5-61B-RED, GENESIS LG NARROW 6" PERF BOTTOM RED; 23. CD5-61C-BLACK, GENESIS LG NARROW 6" SOLID BOTTOM BLACK 24. CD5-61C-BLUE, GENESIS LG NARROW 6" SOLID BOTTOM BLUE; 25. CD5-61C-GOLD, GENESIS LG NARROW 6" SOLID BOTTOM GOLD; 26. CD5-61C-GREEN, GENESIS LG NARROW 6" SOLID BOTTOM GREEN; 27. CD5-61C-PURPLE, GENESIS LG NARROW 6" SOLID BOTTOM PURPLE; 28. CD5-61C-RED, GENESIS LG NARROW 6" SOLID BOTTOM RED.

    Recall: Z-1236-2023 · Reported March 15, 2023

    Enforcement

    Recall Number
    Z-1236-2023
    Event ID
    91572
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2023
    Initiation Date
    January 30, 2023
    Classification Date
    March 9, 2023
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN; 9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE; 10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED; 11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK; 12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE; 13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD; 14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN; 15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE; 16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED; 17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK; 18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE; 19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD; 20. CD5-61B-GREEN, GENESIS LG NARROW 6" PERF BOTTOM GREEN; 21. CD5-61B-PURPLE, GENESIS LG NARROW 6" PERF BOTTOM PURPLE; 22. CD5-61B-RED, GENESIS LG NARROW 6" PERF BOTTOM RED; 23. CD5-61C-BLACK, GENESIS LG NARROW 6" SOLID BOTTOM BLACK 24. CD5-61C-BLUE, GENESIS LG NARROW 6" SOLID BOTTOM BLUE; 25. CD5-61C-GOLD, GENESIS LG NARROW 6" SOLID BOTTOM GOLD; 26. CD5-61C-GREEN, GENESIS LG NARROW 6" SOLID BOTTOM GREEN; 27. CD5-61C-PURPLE, GENESIS LG NARROW 6" SOLID BOTTOM PURPLE; 28. CD5-61C-RED, GENESIS LG NARROW 6" SOLID BOTTOM RED.

    Reason

    Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.

    Code Info

    All lot numbers are involved. UDI/DI: 1. CD5-3B - 10885403019548; 2. CD5-3C - 10885403019555; 3. CD5-61B - 10885403019579; 4. CD5-61C - 10885403019586; 5. CD5-3B-BLACK - 10885403197970; 6. CD5-3B-BLUE - 10885403197949; 7. CD5-3B-GOLD - 10885403197925; 8. CD5-3B-GREEN - 10885403197956; 9. CD5-3B-PURPLE - 10885403197932; 10. CD5-3B-RED - 10885403197963; 11. CD5-3C-BLACK - 10885403196515; 12. CD5-3C-BLUE - 10885403196485; 13. CD5-3C-GOLD - 10885403196461; 14. CD5-3C-GREEN - 10885403196492; 15. CD5-3C-PURPLE - 10885403196478; 16. CD5-3C-RED - 10885403198700; 17. CD5-61B-BLACK - 10885403198038; 18. CD5-61B-BLUE - 10885403198007; 19. CD5-61B-GOLD - 10885403197987; 20. CD5-61B-GREEN - 10885403198014; 21. CD5-61B-PURPLE - 10885403197994; 22. CD5-61B-RED - 10885403198021; 23. CD5-61C-BLACK - 10885403196577; 24. CD5-61C-BLUE - 10885403196546; 25. CD5-61C-GOLD - 10885403196522; 26. CD5-61C-GREEN - 10885403196553; 27. CD5-61C-PURPLE - 10885403196539; 28. CD5-61C-RED - 10885403196560.

    Distribution

    Worldwide distribution - US Nationwide, including Puerto Rico. There was also government/military distribution. The countries of Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United Arab Emirates.

    Quantity

    5,952 devices