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 lacks sterility assurance due to to wrinkles in the paper lidding…
Open FDA's page for this record- Cfres ID
- 221740
- Product res number
- Z-3109-2026
- Event date initiated
- 2026-07-14
- Event date posted
- 2026-09-04
- Recall status
- Open, Classified
- Res event number
- 99525
- Product code
- LRO
- Product description
- Halyard IV Start Kit Non-Sterile REF: KRIV26-02
- Code info
- Lot Number:1658438 7/31/2026 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 470-280-4277
- Root cause description
- Packaging process control
- Product quantity
- 98 Kits
- Distribution pattern
- US Nationwide distribution in the state of NE.
- Reason for recall
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal area.
- Action
On July 14, 2026, Avid Medical Inc. a subsidiary of Owens Minor issued an Urgent Medical Device Recall to affected consignees via email. I Avid Medical Inc. requested consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 1a. Discontinue use of the BD ChloraPrep" Clear - 1 mL and FREPP" Clear 1.5 mL Applicators. 1b. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 2. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 3. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 4. Complete the attached Recall Response Form and return by July 31, 2026.
- 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
