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FDA-Device2026-06-24Class IPACKAGING DEFECT

Arrow International PI Midline midline catheter kits recalled for potential sterility compromise

Arrow
Nationwide distribution

Arrow International midline catheter kits recalled for sterility risk

Arrow International included anesthetic and saline solutions from a supplier with documented quality issues in PI Midline midline catheter kits. The supplier's products showed signs of ineffectiveness and potential sterility problems, which could compromise the safety of these injectable medical devices.

  • Check your facility or clinic for PI Midline kits with lot number 33F24L0236 and UDI-DI 10801902193275
  • Do not use affected kits; contact Arrow International or the FDA for return instructions
  • Review patient records if kits were used and consult your healthcare provider or facility infection control
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
90
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2387-2026

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