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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

FDA recall source

Recall number
Z-3261-2026
Event id
99764
Status
Ongoing
FDA classification
Class II
Recalling firm
AVID Medical, Inc.
Report date
Sep 30, 2026
Posted
Sep 23, 2026
Initiated
Jul 22, 2026
Center classification date
Sep 23, 2026
Product code
LRO
Device type
General Surgery Tray
Reason
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
Packaging process control
Quantity
192 kits (4 cases)
Code info
Kit Model Number: KRIV26-01. UDI-DI: 10809160450109. Lot Number: 1642214. Expiration Date: 7/31/2027
Distribution
US Nationwide distribution.
Voluntary or mandated
Voluntary: Firm initiated
Location
Toano, VA, United States