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Class IOngoingZ-3108-2026

AVID Medical, Inc. recalls Halyard IV START KIT NON-STERILE REF: KRIV26-02

AVID Medical, Inc.Toano, VA, United StatesReported Sep 23, 2026 · 6 days ago
Legal News Analyst ·

Reason for recall

Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Halyard IV START KIT NON-STERILE REF:KRIV26-02
    UDI 10809160460481
    2 affected lots
    165843710809160460481

What the firm is doing

On August 18, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an "Urgent Medical Device Recall Update" to affected consignees via email. The update was due to a revise recall strategy. Initial notification was sent on July 14, 2026. Avid ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified in TABLE 1. 2. Discontinue use of the BD ChloraPrep Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 3. FOR AVID KIT KRIV26-02, IV START KIT NON-STERILE, KIT LOT 1658437: Discard entire kit as it contains the contaminated component BD ChloraPrep" Clear - 1 mL, BD LOT 4032183. 4. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of the actions to take and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return by August 28, 2026. If you have any questions, contact Manager, Regulatory Affairs at 470-280-4277.

DistributionShow details

US Nationwide distribution in the state of NE.

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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