Merit Medical Systems, Inc.
Device Recalls (Class I)
Class I
Z-1575-2026
·
20260401
·
Ongoing
Product
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19...
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, and procedure delay.
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, N...
Source: openFDA Enforcement API