FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International central access kits recalled for supplier quality issues affecting drug sterility

OTHERNationwide distribution

Arrow International SAC kits recalled for sterility concerns

Arrow International included lidocaine, bupivacaine, and saline solutions from a supplier with quality issues in three central access kits. The supplier's quality problems and limited reports of drug ineffectiveness raise concerns that sterility may be compromised, which could lead to serious infection or other life-threatening complications.

  • If you use these kits in a healthcare setting, stop using affected lots immediately
  • Check your inventory against the lot numbers: 33F26C0515, 33F26C0517, and 33F26C0518
  • Contact your supplier or Arrow International for instructions on returns or replacement
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
0
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2390-2026

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