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Recall Observatory FDA recall evidence

Device product

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.

Z-1236-2023

January 30, 2023

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 91572
Status
Ongoing
Classification
Class II
Quantity
5,952 devices
Official record key
device-enforcement:Z-1236-2023

Official wording

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

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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