# FDA recall Z-1236-2023

> **Carefusion 2200 Inc** · Class II · device recall initiated 2023-01-30.

## 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" SOL

## 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.

## Key facts

- **Recall number:** Z-1236-2023
- **Recalling firm:** Carefusion 2200 Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-30
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vernon Hills, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1236-2023

## Citation

> AI Analytics. FDA recall Z-1236-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1236-2023. Source: US FDA. Licensed CC0.

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