Arrow International ACCESS TRAY kits recalled for compromised sterility of injectable drugs
Arrow International ACCESS TRAY recalled for sterility concerns
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.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2026More ARROW INTERNATIONAL, LLC recalls
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- FDA-Device2026-06-24Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A
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