[pending] GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneo
Pending LLM rewrite. Source: FDA_DEVICE Z-1731-2025.
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
Due to a potential open seal in the sterile barrier packaging .
The recalled product
- Product
- GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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