FDA-Device2026-06-24Class IPACKAGING DEFECT

Arrow International PI JACC catheter kits recalled for contaminated injectable components

Nationwide distributiondevice

Arrow International JACC kits recalled for contaminated injectables

Arrow International JACC catheter kits contain lidocaine, bupivacaine, and sodium chloride from a supplier with quality control problems. The injectable components may not work properly or could be sterile-compromised, risking serious infection if used.

  • Check if your facility received any affected PI JACC or AGBA PI JACC kits (see lot numbers in recall notice)
  • Stop using affected lots immediately and quarantine them
  • Contact Arrow International or your supplier for return instructions
  • Consult the full FDA recall notice for complete lot and UDI information
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.

Who it affects
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
1,516
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2379-2026

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