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Recall Observatory FDA recall evidence

Device product

Description/REF: ACCESS TRAY/ASK-04001-MC3

Z-2392-2026

April 21, 2026

Class I

Product summary

Firm
ARROW INTERNATIONAL, LLC
Event
Event 98793
Status
Ongoing
Classification
Class I
Quantity
8,265
Official record key
device-enforcement:Z-2392-2026

Official wording

Reason: 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.

Code information: REF(Material)/UDI-DI/Lot(Batch): ASK-04001-MC3/

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.