Merit Medical Systems, Inc.: PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/

Company / brand

Merit Medical Systems, Inc.

Product

PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

Reason / hazard

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Classification

Class II

Status

Ongoing

Distribution / sold at

US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, Japan

Recall initiated

2025-08-04

Code info

REF/UDI-DI/Lot(Expiration): IN4802/K/00884450638385/I3138883(20-FEB-2028), I3150031(27-FEB-2028), I3161209(10-MAR-2028), I3161210(08-APR-2028), I3161211(17-MAR-2028), I3172451(30-NOV-2026); IN4802/T/00884450860113/I3135188(30-NOV-2026, I3170171(10-MAR-2028; IN4918/A/00884450638521/I3146050(20-FEB-2028), I3200779(19-MAY-2028); IN7802/C/00884450498743/H3143753(30-NOV-2026), H3162387(14-MAR-2028), H3183068(31-MAR-2028), H3189446(29-FEB-2028), H3213617(31-MAY-2028); IN8802/C/00884450621417/H3141570(02-FEB-2028), H3143769(03-FEB-2028), H3143770(31-DEC-2026), H3143771(03-FEB-2028), H3143772(03-FEB-2028), H3149478(17-FEB-2028), H3149480(31-DEC-2026), H3149483(31-DEC-2026), H3155549(24-FEB-2028), H3162422(14-MAR-2028), H3162627(14-MAR-2028), H3168247(07-MAR-2028), H3183054(31-DEC-2026), H3200495(26-APR-2028), H3219087(10-JUN-2028), H3241812(31-MAY-2028); IN9802/00884450413463/H3141573(21-MAR-2028), H3183200(28-MAR-2028); IN9802/A/00884450021347/H3200469(26-APR-2028), H3210336(30-NOV-2026); K05-02166B/00884450499597/T3192808(24-FEB-2027), T3198985(11-AUG-2027), T3201276(27-FEB-2027), T3217490(02-SEP-2027); K05T-02138A/ 00884450095607 T3232335(15-AUG-2027); K12T-10798A/00884450544372/T3163727(21-MAY-2027), T3217266(20-FEB-2026); MAP800/B/ 00884450746714/I3124454(07-JAN-2028), I3174736(10-MAR-2028), I3186951(24-MAR-2028), I3191334(01-APR-2028), I3206933(21-APR-2028), I3209939(29-APR-2028), I3219784(12-MAY-2028), I3219792(12-MAY-2028), I3234557(19-MAY-2028), I3234558(26-MAY-2028); MAP800/T/00884450003985/I3162929(10-MAR-2028), I3162931(17-MAR-2028), I3186954(17-MAR-2028), I3186961(15-APR-2028); MAP801/B/00884450746721/I3146099 (24-MAR-2028), I3186946(21-APR-2028), I3209937(31-DEC-2026); MAP802/B/00884450746745/I3118322(21-JAN-2028), I311832407-JAN-2028), I3129725(06-FEB-2028), I3129726(06-FEB-2028), I3150110(20-FEB-2028), I3150111(20-FEB-2028), I3162940(27-FEB-2028), I3162942(03-MAR-2028), I3174729(03-MAR-2028), I3174730(17-MAR-2028), I3192937(15-APR-2028), I3200996(15-APR-2028), I3209935(29-APR-2028), I3215925(29-APR-2028), I3215926(30-APR-2028), I3215928(05-MAY-2028), I3219783(30-APR-2028), I3219785(19-MAY-2028), I3219786(19-MAY-2028), I3230013(26-MAY-2028); MAP802/CNB/00884450746752/I3174740(08-APR-2028); MAP802/T/00884450860939/I3162943(17-MAR-2028), I3192650(08-APR-2028), I3192654(22-APR-2028); MAP804/B/00884450746783/I3146101(31-OCT-2027), I3161426(31-DEC-2027); MAP852/B/00884450746820/I3187883(28-FEB-2028); SKY1802/00884450822500/H3079946(20-OCT-2027), H3141576(21-MAR-2028), H3141577(21-MAR-2028), H3149507(28-MAR-2028), H3149508(28-MAR-2028), H3155575(21-MAR-2028), H3155576(21-MAR-2028), H3155577(21-MAR-2028), H3155578(14-MAR-2028), H3168264(29-FEB-2028), H3168265(29-FEB-2028), H3182996(28-MAR-2028), H3183206(31-MAR-2028), H3183207(31-MAR-2027), H3189428(12-APR-2028), H3189451(12-APR-2028), H3200416(19-APR-2028), H3200475(19-APR-2028), H3219111(30-NOV-2026)

Product quantity

217,141

Voluntary mandated

Voluntary: Firm initiated

City

South Jordan

State

UT

Country

United States

Event id

97446

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