FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International paracentesis kit recalled for contaminated anesthetic drugs

OTHERNationwide distribution

Arrow International paracentesis kit recalled for drug contamination

Arrow International included anesthetic drugs (lidocaine and bupivacaine) and saline solution from a supplier with quality problems into paracentesis kits. The supplier had reports of drug ineffectiveness, and if the sterility of these injectable products was compromised, patients could face serious injury.

  • If you have kit ASK-00376-JHH (lots 33F25G0629 or 33F24K0592), do not use it.
  • Contact Arrow International or your healthcare facility for instructions on replacement or safe disposal.
  • Healthcare providers should quarantine affected kits and review patient records for any kits already used.
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
180
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: PARACENTESIS KIT/ASK-00376-JHH

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2386-2026

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