Device recalls

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, ClassifiedPackaging process controlZ-3109-2026
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.