The Recall Desk
HighFDA (Devices)·Z-1236-2023·Announced 2023-03-15

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.

What this means for you

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 C
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Surgical Equipment Storage / Sterilization
Hazard
  • sterility-breach
  • shelf-life-testing-failure

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

Distributed nationwide across the United States.

Related recalls

Same category