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Home › FDA recalls › Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B
CLASS I · SeriousFDA

ARROW INTERNATIONAL, LLC recalls Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B

📅 Apr 21, 2026 · 📍 Nationwide
Recalling company
ARROW INTERNATIONAL, LLC
Product
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
Reason
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 – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Apr 21, 2026
Reported
Jun 24, 2026
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.
Status
Ongoing
Quantity
0
Lot / codes
REF(Material)/UDI-DI/Lot(Batch): SAC-01218-B/10801902225303/33F26C0515; SAC-01218-C/10801902225273/33F26C0517; SAC-01618-B/10801902225310/33F26C0518
Company location
Morrisville, NC
Recall type
Voluntary: Firm initiated
Recall number
Z-2390-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2390-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.