Recall of CentrosFLO Hemodialysis Catheters

What Happened

The recall is due to a design defect in the 16F dual-valved splittable sheath introducer, which may not split as intended, potentially resulting in hemorrhage, foreign bodies, and procedure delays.

Which Products Are Affected

The affected products include various models of CentrosFLO Hemodialysis Catheters, such as REF: CENFP15K/A, 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, and CENFT31K/D. A total of 35,591 units are affected, with distribution in the United States nationwide to states including 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 internationally to countries such as Canada, Spain, and others. The official recall number is Z-1575-2026.

What You Should Do

Consumers should check if their device matches the affected models and lots, and contact Merit Medical Systems, Inc. at their address: 1600 W Merit Pkwy, South Jordan, UT 84095-2416, for information on returns or refunds related to this voluntary recall.

Why This Matters

This Class I recall highlights a serious risk of adverse health effects, including hemorrhage, which could lead to significant patient harm, underscoring the need for immediate verification and action by users.

Source

FDA Recall: Z-1575-2026 (attribution to FDA)