Z-3109-2026 Class II Ongoing
FDA device recall Z-3109-2026 was initiated by AVID Medical, Inc. on July 14, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 98 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2026
- Initiation Date
- July 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 Kits
Product Description
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.
Distribution Pattern
US Nationwide distribution in the state of NE.
Code Information
Lot Number:1658438 7/31/2026 UDI: 10809160460481