Integra LifeSciences Corp. (NeuroSciences): MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application

Hazard

Lack of sterility assurance.

Details from the source

Reason for recall: Lack of sterility assurance. 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. Quantity: 4,882 units Lot/code info: Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.

UPC codes

10381780000112

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.