FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International Pacing PSI Kits recalled for potential drug ineffectiveness and sterility compromise

Nationwide distribution

Arrow International Pacing PSI Kits recalled for sterility and drug concerns

Arrow International included local anesthetic drugs (lidocaine and bupivacaine) from a supplier with quality issues into several pacing procedure kits. The supplier's drugs had limited reports of ineffectiveness, and compromised sterility in injectable products could cause serious infection or other life-threatening complications.

  • Check if your facility received any Pacing PSI Kits with the affected lot numbers listed in the recall notice.
  • Do not use affected kits; quarantine them and contact Arrow International or the FDA if you have questions.
  • Contact your hospital's pharmacy, procurement, or medical device team to verify whether your inventory is affected.
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.

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
15,915
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2366-2026

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