Merit Medical Systems, Inc.: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H7871030

Hazard

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Details from the source

Reason for recall: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. Distribution: Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, B Quantity: 21,591 Lot/code info: REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618; H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154; H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627; H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443; H787103028055/A:00884450794579/I3178903); H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619; H787103028075/A:00884450794609/I2995817), I3209313, I3270826; H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444; H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581; H787103028165/A:00884450794647/I3049563; H787103028181/A:00884450794661/I2929317, I3178900, I3208675; H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157; H787103028191/A:00884450794678/I2909758; H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042; H787103028205/A:00884450794692/I292

UPC codes

00884450794524, 00884450794548, 00884450786130, 00884450794555, 00884450786161, 00884450794562, 00884450794579, 00884450794586, 00884450794609, 00884450794623, 00884450794630, 00884450794647, 00884450794661, 00884450786178, 00884450794678, 00884450786185, 00884450794692, 00884450794708, 00884450794715, 00884450842249

Source

Official record: FDA (Device enforcement) ↗

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