AVID Medical, Inc. recalls 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
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:KRIV26-02UDI 108091604604812 affected lots165843710809160460481
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 detailsHide
US Nationwide distribution in the state of NE.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3108-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
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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