[pending] CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-12
Pending LLM rewrite. Source: FDA_DEVICE Z-1683-2026.
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
- CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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