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ARROW INTERNATIONAL, LLC: Description/REF: PARACENTESIS KIT/ASK-00376-JHH

Medical DevicesSource: FDA (device) · Date: 2026-06-24

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ARROW INTERNATIONAL, LLC
Product
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Reason / 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.
Classification
Class I
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-04-21
Code info
REF(Material)/UDI-DI/Lot(Batch): ASK-00376-JHH/10801902193275/33F25G0629, 33F24K0592
Product quantity
180
Voluntary mandated
Voluntary: Firm initiated
City
Morrisville
State
NC
Country
United States
Event id
98793
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