[pending] Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135
Pending LLM rewrite. Source: FDA_DEVICE Z-1685-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
The recalled product
- Product
- Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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