FDA Recall Open, Classified

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

Recall: Z-1575-2026 · Initiated February 13, 2026

Recall

Recall Number: Z-1575-2026
Event Number: 98464
Firm: Merit Medical Systems, Inc.
FEI Number: 1721504
Product Code: MSD
Status: Open, Classified
Root Cause: Process control
Initiated: February 13, 2026
Posted: March 26, 2026
Address: 1600 W Merit Pkwy South, Jordan, UT, 84095-2416

Description

Reason

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.

Action

On 2/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: A picture of the 16F Dual-Valved Splittable Sheath Introducer is attached to help you identify the product. Place this notice and the picture on or near the affected product in your inventory (if applicable). Discontinue the use of the 16F Dual-Valved Splittable Sheath Introducer and destroy the sheath introducer at the point of use. Ensure that applicable personnel within your organization are made aware of this field action. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Complete and return the customer response form via email to [email protected] If you have any questions concerning this communication, contact the firm's Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri. On 4/2/2026, revised notices were mailed to customers that included stickers to be placed on affected devices to ensure awareness of the recall.

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, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Quantity

35,591