Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a sterility breach in surgical sterilization containers—a high-risk product category. However, no illnesses, injuries, or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Carefusion 2200 Inc is recalling the CD5 Series of Genesis Reusable Rigid Sterilization Container Systems. According to the FDA, the products did not meet shelf-life testing requirements, resulting in a breach of the sterility of these containers used to hold surgical equipment.
Sterilization containers are critical devices for protecting surgical instruments from contamination. A breach of sterility means these containers may not maintain the required protective environment for instruments stored within them, potentially allowing contamination that could affect surgical safety.
The recall affects 5,952 devices across multiple product variants. The affected containers were distributed worldwide, including throughout the United States and Puerto Rico, as well as to government and military organizations. International distribution included Australia, Canada, Denmark, Finland, Hong Kong, Ireland, Japan, Malaysia, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, and United Arab Emirates. All lot numbers of the affected product lines are included in the recall.
The recalled product
- 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…
- Manufacturer
- Carefusion 2200 Inc
- Affected units
- 5,952
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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