FDAClass I · Medical device · Recalled June 24, 2026

Description/REF recall — ARROW INTERNATIONAL, LLC

Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2395-2026
Brand: ARROW INTERNATIONAL
Classification: Class I
Units affected: 360
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

Affected products

Description/REF

Companies & origin

Recalling firm location: Morrisville, NC, United States
Firm address: 3015 Carrington Mill Blvd, 27560-5437

Identifying details (verbatim from the notice)

Product codes / lots: REF(Material)/UDI-DI/Lot(Batch): ASK-04001-CG1/10801902193275/33F25C0224, 33F25D0647, 33F25G0390, 33F25J0348
Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Firm notified the public via: Letter
FDA event ID: 98793
Recall initiated: April 21, 2026
FDA classified: June 12, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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