[pending] CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 S
Pending LLM rewrite. Source: FDA_DEVICE Z-1681-2026.
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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 00081317006671 00081317006794 00081317006800
Distribution
Distributed nationwide across the United States.
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