FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International ACCESS TRAY kits recalled for compromised sterility of injectable drugs

OTHERNationwide distributionMedical devices

What this means

Arrow International's ACCESS TRAY kits (model ASK-04001-MC3) contain injectable anesthetic and saline solutions from a supplier with documented quality issues. If the sterility of these water-based injectables has been compromised, serious or life-threatening infections could result. The supplier also reported limited cases of drug ineffectiveness.

Stop using affected ACCESS TRAY kits immediately if you have them.
Check your inventory for model ASK-04001-MC3 and cross-reference against recalled lot numbers.
Contact Arrow International or your supplier for instructions on return or safe disposal.
Consult your healthcare facility's pharmacy or compliance officer for next steps.

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

8,265

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2026

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