Class 2 Device Recall Halyard

• Date Initiated by Firm: July 22, 2026
• Date Posted: September 23, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3261-2026
• Recall Event ID: 99764
• Product Classification: General surgery tray - Product Code LRO
• Product: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
• Code Information: Kit Model Number: KRIV26-01. UDI-DI: 10809160450109. Lot Number: 1642214. Expiration Date: 7/31/2027
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; +1-470-2804277
• Manufacturer 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.
• FDA Determined 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. 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.
• Quantity in Commerce: 192 kits (4 cases)
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.