FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
- Recall number
- Z-3194-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.
- Status
- Open, Classified
- Initiated
- 2026-07-22
- Posted
- 2026-09-23
- Terminated
- not on file
- Reason
- Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
- Root cause
- Packaging process control
- 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.
- Quantity
- 288 kits (6 cases)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Kit Model Number: KRIV26-02. UDI-DI: 10809160460481. Lot Number: 1658437. Expiration Date: 1/31/2027
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28