FDA-Device2026-06-24Class IPACKAGING DEFECT
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Nationwide distribution
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
7560
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2380-2026More ARROW INTERNATIONAL, LLC recalls
- FDA-Device2026-06-24Arrow International epidural catheter kits recalled for potentially compromised anesthetic sterility
- FDA-Device2026-06-24Arrow International hemodialysis and AHDC kits recalled for contaminated injectable anesthetics and saline
- FDA-Device2026-06-24Description/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
- FDA-Device2026-06-24Arrow International central venous catheter kits recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International paracentesis kit recalled for contaminated anesthetic drugs
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