CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONT... — FDA record Z-1236-2023

What the record says

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.

Reason

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

Classification

Class II

Recalling firm

Carefusion 2200 Inc

Quantity

5,952 devices

Agency-reported status

Ongoing

Source record identifier

Z-1236-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

• Alaska
• Alabama
• Arkansas
• Arizona
• California
• Colorado
• Connecticut
• Delaware
• Florida
• Georgia
• Hawaii
• Iowa
• Idaho
• Illinois
• Indiana
• Kansas
• Kentucky
• Louisiana
• Massachusetts
• Maryland
• Maine
• Michigan
• Minnesota
• Missouri
• Mississippi
• Montana
• North Carolina
• North Dakota
• Nebraska
• New Hampshire
• New Jersey
• New Mexico
• Nevada
• New York
• Ohio
• Oklahoma
• Oregon
• Pennsylvania
• Rhode Island
• South Carolina
• South Dakota
• Tennessee
• Texas
• Utah
• Virginia
• Vermont
• Washington
• Wisconsin
• West Virginia
• Wyoming

Dates in the source

Report date

Mar 15, 2023

Recall initiation date

Jan 30, 2023

Center classification date

Mar 9, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.