FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International PICC Access Tray recalled for compromised sterility of injectable medications

OTHERNationwide distribution

Arrow International PICC Access Tray recalled for sterility risk

Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with known quality issues in PICC Access Tray kits. The supplier's products have reported cases of drug ineffectiveness, and compromised sterility in injectable medications can cause serious injury. About 360 kits with specific lot numbers were distributed nationwide.

  • If you have a PICC Access Tray with lot numbers 33F25C0224, 33F25D0647, 33F25G0390, or 33F25J0348, do not use it.
  • Contact your healthcare provider or Arrow International for instructions on safe replacement or disposal.
  • Report any adverse effects 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
360
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2395-2026

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