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FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International pacing/PSI kit recalled for compromised sterility of injectable anesthetics

Arrow
Nationwide distribution

Arrow International pacing kit recalled for anesthetic sterility risk

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in pacing/PSI kits. The supplier's products had limited reports of drug ineffectiveness, and if the sterility of these injectable products is compromised, it could cause serious or life-threatening injury. Approximately 95 kits were distributed nationwide.

  • If you have an affected kit (model ASK-07155-MGU, lot 33F25C0798), do not use it.
  • Contact your healthcare provider or Arrow International for guidance on replacement or proper disposal.
  • Report any adverse events or product issues to the FDA MedWatch program.
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
95
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2383-2026

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