MicroMyst Applicator recalled due to lack of sterility assurance
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which under the rubric requires a minimum score of 4. A sterility assurance failure in a medical device used for controlled fluid application presents serious potential for infection and patient harm.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling the MicroMyst Applicator, Box of 5 (Model/Catalog Number 205000DS), due to lack of sterility assurance. The MicroMyst Applicator consists of a multilumen applicator and filtered line for use with the Integra Flow Source for controlled application of two liquids.
A total of 4,882 units have been distributed worldwide, including throughout the United States and to Taiwan (Province of China), Vietnam, 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 the United Kingdom. All lots of the product (UDI No. 10381780000112) are affected.
Patients and healthcare providers who have this product should contact Integra LifeSciences Corp. for further instructions regarding this recall.
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)
- Affected units
- 4,882
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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