ARROW INTERNATIONAL, LLC — Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1;
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 21, 2026
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.
What's affected?
- Product
- Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1
- Lot code
- (Batch):
Additional details
REF(Material)/UDI-DI/Lot(Batch): DLX-45563-VPSB/10801902193275/33F25C0704, 33F25D0316, 33F25D0627, 33F25M0094, 33F24L0860; DLX-45563-VPSC/10801902193275, 10801902208658, 10801902210118/33F25B0509, 33F25C0340, 33F25D0255, 33F25D0628, 33F25E0767, 33F25E0901, 33F25F0227, 33F25J0448, 33F25K0036, 33F26C0104, 33F26C0107, 33F24C0257; ASK-04001-UCHD1/10801902193275, 10801902219005/33F25H0415, 33F25J0349, 33F26B0440, 33F24L0396; ASK-04001-UCHS1/10801902193275, 10801902219067/33F24L1083, 33F25D0331, 33F25E0521, 33F25E0846, 33F25K0068, 33F25K0107, 33F25M0133, 33F26A1417, 33F26C0029, 33F24K0406; ASK-04001-DU13/10801902193275, 10801902201970/33F25B0514, 33F25C0703, 33F25F0090, 33F25F0124, 33F25H0421, 33F25J0197, 33F26A1372, 33F26B0850, 33F26C0369, 33R25A0227, 33F24K0314; ASK-04001-UNHS1/10801902193275, 10801902211887, 10801902158854/33F25A0229, 33F25C0714, 33F25D0390, 33F25E0847, 33F25G0244, 33F25M0129, 33F26A1139, 33F26C0370, 33F24E0400
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 11,358.
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