# FDA recall Z-2396-2026

> **ARROW INTERNATIONAL, LLC** · Class I · device recall initiated 2026-04-21.

## Product

Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2396-2026
- **Recalling firm:** ARROW INTERNATIONAL, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-21
- **Report date:** 2026-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2026

## Citation

> MORVS. FDA recall Z-2396-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2396-2026. Source: US FDA. Licensed CC0.

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