FDA DeviceClass IINotable

FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135U

Date: 2026-04-08
Brand: Mentor Texas, LP.
Category: Medical Device
FDA Class: Class II

Description

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

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