Carefusion 2200 Inc: 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 L

Hazard

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

Details from the source

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

UPC codes

10885403019548, 10885403019555, 10885403019579, 10885403019586, 10885403197970, 10885403197949, 10885403197925, 10885403197956, 10885403197932, 10885403197963, 10885403196515, 10885403196485, 10885403196461, 10885403196492, 10885403196478, 10885403198700, 10885403198038, 10885403198007, 10885403197987, 10885403198014, 10885403197994, 10885403198021, 10885403196577, 10885403196546, 10885403196522, 10885403196553, 10885403196539, 10885403196560

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.