Z-3108-2026 Class I Ongoing
FDA device recall Z-3108-2026 was initiated by AVID Medical, Inc. on July 14, 2026 and is designated Class I. Reason for recall: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides The recall status is ongoing. Affected quantity: 288 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 units
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 are contaminated with Aspergillus penicillioides
Distribution Pattern
US Nationwide distribution in the state of NE.
Code Information
Lot Number: 1658437 UDI: 10809160460481