Merit Medical Systems, Inc.: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C

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: 131 Lot/code info: REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169; DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C:00884450697924/H2600164, H2628890; DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C:00884450697948/H2630602; DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229

UPC codes

00884450697870, 00884450697900, 00884450697894, 00884450697924, 00884450697917, 00884450697948, 00884450697962, 00884450697979

Source

Official record: FDA (Device enforcement) ↗

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