FDA-Device2026-06-24Class IPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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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