Recall Z-3109-2026
- Recall number
- Z-3109-2026
- Event number
- 99525
- Firm
- AVID Medical, Inc.
- Firm FEI
- 1047429
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-07-14
- Posted
- 2026-09-04
- Root cause
- Packaging process control
- 510(k) numbers
- K970187, K871434, K890570, K902887, K935741, K935740, K023276, K931758, K980137, K950574, K945831, K872448, K890726, K872011, K914037, K914036, K920267, K932221, K924468, K895202, K931760, K951149, K961863, K920292, K854292, K934428, K874439, K910365, K963443, K913136
Product#
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Reason for Recall#
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.