Z-3194-2026 Class I Ongoing
FDA device recall Z-3194-2026 was initiated by AVID Medical, Inc. on Jul 22, 2026 and is designated Class I. Reason for recall: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides. The recall status is ongoing. Affected quantity: 288 kits (6 cases).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Jul 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 kits (6 cases)
Product Description
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
Reason for Recall
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
Distribution Pattern
US Nationwide distribution.
Code Information
Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027