Halyard IV START KIT NON-STERILE REF: KRIV26-02
AVID Medical, Inc. · Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
Open FDA's page for this record- Cfres ID
- 222151
- Product res number
- Z-3108-2026
- Event date initiated
- 2026-07-14
- Event date posted
- 2026-09-14
- Recall status
- Open, Classified
- Res event number
- 99672
- Product code
- LRO
- Product description
- Halyard IV START KIT NON-STERILE REF: KRIV26-02
- Code info
- Lot Number: 1658437 UDI: 10809160460481
- Firm FEI number
- 1047429
- Recalling firm
- AVID Medical, Inc.
- Address 1
- 9000 Westmont Dr
- City
- Toano
- State
- VA
- Postal code
- 23168-9351
- Additional info contact
- Marlene Jones +1-470-2804277
- Reason for recall
- Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
- Root cause description
- Packaging process control
- Product quantity
- 288 units
- Distribution pattern
- US Nationwide distribution in the state of NE.
- Action
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.
- Harmonized identifiers (openFDA)
- Device name
- General Surgery Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- K number
- K854095, K926269, K854292, K962826, K941846, K945160, K963721, K030721, K890570, K935483, K895202, K903336, K894685, K932221, K902887, K980137, K871873, K935740, K925467, K884093, K951149, K023276, K970187, K871322, K901856, K871434, K890098, K905459, K885090, K951478, K902888, K871437, K041080, K905004, K932220, K935743, K910365, K935686, K892389, K925016 +70 more
- Registration number
- 1417592, 3004361903, 1526711, 2431166, 3014704068, 3005997949, 2029275, 3004111573, 3017430544, 3011494917, 3005669815, 3019798849, 1423395, 3006846316, 3004122598, 3020983482, 1000124971, 1055892, 2024980, 3004513970, 3018116884, 2000028362, 3042480961, 3007344957, 3005400762, 3006891803, 1643817, 3005246893, 1527607, 3004605321, 1063382, 1644019, 2936485, 3023140882, 3005012805, 3006973666, 3013466775, 3007139365, 1650907, 1824619 +122 more
- FEI number
- 1417592, 3004361903, 3003803331, 3002692512, 1526711, 1000121355, 3014704068, 1000514656, 3005997949, 3017430544, 3004111573, 3019798849, 3011494917, 3005669815, 3006846316, 3008875470, 3004122598, 3020983482, 1000124971, 3004513970, 3018116884, 2000028362, 3042480961, 3007344957, 3005400762, 3006891803, 1643817, 1000123297, 3005246893, 1527607, 3004605321, 2936485, 3023140882, 3003807323, 3005012805, 3006973666, 1000112877, 3013466775, 3007139365, 1000160458 +122 more
