[pending] MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with
Pending LLM rewrite. Source: FDA_DEVICE Z-1961-2025.
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
Lack of sterility assurance.
The recalled product
- Product
- MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- 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 (3)
- Model/Catalog Number: 205000DS
- UDI No. 10381780000112
- All lots.
Distribution
Distributed nationwide across the United States.
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