FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International PI CVC kits recalled for compromised sterility and drug ineffectiveness

OTHERNationwide distributionMedical devices

What this means

Arrow International included anesthetic and saline components from a supplier with quality issues in several percutaneous 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.

If you use or have these kits (ASK-42703-PNHS2, ASK-45703-PNHS2, or ASK-45854-PNHS2), stop using them immediately.
Contact your healthcare facility or Arrow International for instructions on returning or disposing of affected kits.
Check lot numbers 33F25J0107, 33F25B0593, and 33F24H0128 against your inventory.

Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓

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

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2375-2026

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.