FDA DeviceClass INotable

FDA Recall: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A,

Date: 2026-04-01
Brand: Merit Medical Systems, Inc.
Category: Medical Device
FDA Class: Class I

Description

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.

Hazard

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.

Remedy

35,591

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