Merit Medical Systems, Inc.: Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S0

Hazard

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Details from the source

Reason for recall: Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Brazil, Canada, Cayman Island, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Republic Quantity: 52,410 (updated 06/14/2024) Lot/code info: Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566 00884450531709 H2800559 00884450531709 H2808568 00884450531709 H2817152 00884450531709 H2830841 00884450531709 H2839229 00884450531709 H2852688 00884450531709 PG4F90S H2418703 00884450531716 H2478781 00884450531716 H2532524 00884450531716 H2542736 00884450531716 H2642436 00884450531716 H2662245 00884450531716 H2668984 00884450531716 H2684572 00884450531716 H2757247 00884450531716 H2763317 00884450531716 H2876572 00884450531716 PG5F45MP H2409290 00884450531914 H2478782 00884450531914 H2542737 00884450531914 H2633727 00884450531914 H2655894 00884450531914 H2662249 00884450531914 H2684571 00884450531914 H2722066 00884450531914 H2757249 00884450531914 H2777503 00884450531914 H2785759 00884450531914 H2821571 00884450531914 H2830842 00884450531914 PG5F45R H2418694 00884450531921 H2474337 00884450531921 H2532525 00884450531921 H2569083 00884450531921 H2684579 00884450531921 H2722072 00884450531921 H2757250 00884450531921 H2785760 00884450531921 H2800565 H2918260 PG5F45S H2412933 00884450531730 H2418701 00884450531730 H2460087 00884450531730 H2510831 00884450531730 H2542738 00884450531730 H2589671 00884450531730 H2598840 00884450531730 H2633728 00884450531730 H2652758 00884450531730 H2655895 00884450531730 H2673477 00884450531730 H2684561 008844505

UPC codes

00884450531709, 00884450531716, 00884450531914, 00884450531921, 00884450531730, 00884450770757, 00884450531952, 00884450531945, 00884450770764, 00884450557501, 00884450532065, 00884450532133, 00884450531969, 00884450770771, 00884450532157, 00884450532140, 00884450532164, 00884450532171, 00884450532317, 00884450532300, 00884450770788, 00884450532348, 00884450532522, 00884450532539, 00884450532324, 00884450532515, 00884450532546, 00884450532553, 00884450532584, 00884450532560, 00884450532577, 00884450532591, 00884450532607, 00884450732311

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.