FDA-Device2026-06-24Class IPACKAGING DEFECT

Arrow International peritoneal lavage catheter kits recalled for compromised sterility of anesthetic components

Nationwide distributiondevice

Arrow International peritoneal lavage kits recalled for sterility risk

Arrow International's 8FR peritoneal lavage catheter kits contain anesthetic medications (lidocaine and bupivacaine) from a supplier with known quality issues. If the sterility of these injectable components is compromised, patients could face serious injury or infection.

  • Stop using affected kits immediately if you have them in inventory
  • Check your lot numbers against the FDA's list to confirm if your kits are affected
  • Contact Arrow International or your distributor for instructions on return or replacement
  • Do not use any affected kits on patients
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
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-2380-2026

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