Device recall enforcement reports

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…

Class IIOngoingZ-3109-2026
Status
Ongoing
City
Toano
State
VA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99525
Recalling firm
AVID Medical, Inc.
Address 1
9000 Westmont Dr
Postal code
23168-9351
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
E-Mail
Distribution pattern
US Nationwide distribution in the state of NE.
Recall number
Z-3109-2026
Product description
Halyard IV Start Kit Non-Sterile REF: KRIV26-02
Product quantity
98 Kits
Recall initiation date
20260714
Center classification date
20260904
Report date
20260916
Code info
Lot Number:1658438 7/31/2026 UDI: 10809160460481
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.

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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.