← FDA ENFORCEMENT
Z-2156-2026Class I

ARROW INTERNATIONAL, LLC

Recalling firm
ARROW INTERNATIONAL, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW
Firm state
NC
Product quantity
285
Initiated by
Voluntary: Firm initiated
Reason for recall

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Product description

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Code / lot info

REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.