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FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International CVC kits recalled for potentially ineffective anesthetic and compromised sterility

Arrow
OTHERNationwide distribution

Arrow International CVC kits recalled for sterility and anesthetic concerns

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in three models of central venous catheter (CVC) kits. The supplier's products showed limited reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

  • Check if you have affected CVC kits: models AK-04210, AK-04300, or CK-04711
  • Review lot numbers on affected kits against the FDA notice
  • Contact your supplier or Arrow International for instructions on return or replacement
  • Do not use affected kits if sterility is in question
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
35,540
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2026

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