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FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International AHDC and LBCVC catheter kits recalled for compromised injectable sterility

Arrow
OTHERNationwide distribution

Arrow International catheter kits recalled for sterility concerns

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality issues in several catheter kit models. If the sterility of these water-based injectable products is compromised, patients could face serious or life-threatening infections.

  • Check if you have any affected kit lot numbers (full list available in recall details)
  • Do not use affected kits; contact your healthcare provider or hospital pharmacy for replacement
  • Return unused kits to your supplier or contact Arrow International for instructions
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
4,270
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XP1A; AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPN1A; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A-U; LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XN1A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2374-2026

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