Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
AVID Medical, Inc. · Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Open FDA's page for this record- Cfres ID
- 222429
- Product res number
- Z-3260-2026
- Event date initiated
- 2026-07-22
- Event date posted
- 2026-09-23
- Recall status
- Open, Classified
- Res event number
- 99764
- Product code
- LRO
- Product description
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02
- 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 containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
- Root cause description
- Packaging process control
- Product quantity
- 816 kits (17 cases)
- Distribution pattern
- US Nationwide distribution.
- Code info
Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Numbers (Expiration Date): 1658438 (07/31/2026), 1685838 (12/19/2027), 1699753 (02/28/2027), 1706455 (12/19/2027).
- Action
Consignees were initially notified on about 07/22/2026 via "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. They were informed that product may exhibit an open or incomplete seal on the packaging of the applicator. Consignees were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed. Consignees were notified again on about 08/20/2026 with an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. Consignees were informed that certain lots of the BD ChloraPrep Applicators are contaminated with Aspergillus penicillioides. Instructions included to discard impacted kits containing affected applicators and notify customers if the kits had been further distributed. For those unaffected by the contamination, but are included in the action regarding sterility concerns, they were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed.
- 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