Notice names this product. ARROW INTERNATIONAL’s PARACENTESIS KIT is named in FDA Class I recall Z-2363-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported 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. Identifying details: REF(Material)/UDI-DI/Lot(Batch): AK-00376/10801902197938, 10801902193275, 10801902197938, 10801902197952/33F24D0004, 33F24E0166, 33F24G0318, 33F24J0486, 33F24K0083, 33F24L0725, 33F25A0453, 33F25A0610, 33F25C0749, 33F25C0906, 33F25E0031, 33F25G0075, 33F25H0007, 33F25H0719, 33F25J0739, 33F25J0817, 33F25L0462, 33F25M0954, 33F26B0949, 33F26C0575, 33F24A0016; ASK-00376-VCU/10801902193275, 10801902138788/33F24L0522, 33F24M0088, 33F25C0060, 33F25D0282, 33F25F0257, 33F25G0746, 33F25J0602, 33F24D0201. Units affected: 50,724. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Agency product description and boundaries
PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 repo…