MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use w...
FDA Recall #Z-1961-2025 — Class I — May 23, 2025
Product Description
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.
Reason for Recall
Lack of sterility assurance.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
4,882 units
Distribution
Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
Code Information
Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated