MicroMyst applicator and extended tip applicators
Last updated
Summary
Product
MicroMyst applicator and extended tip applicators
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Extended Tip Applicator - Single Use Applicator 15 Cm | More than 10 numbers, contact manufacturer. | 205115 |
| MicroMyst Applicator | More than 10 numbers, contact manufacturer. | 205000DS |
| Extended Tip Applicator - Single Use Applicator 8 Cm | More than 10 numbers, contact manufacturer. | 205108 |
Issue
The decision to conduct a recall of the MicroMyst applicator and extended tip applicators was based on internal investigation that demonstrated an incomplete bioburden assessment and an incomplete sterilization location transfer documentation to ensure the effectiveness of the sterilization process.
The investigation also identified that the extended tip applicators, exclusively, could potentially contain out-of-specification levels of endotoxin.
Recall start date: June 2, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
| Integra Lifesciences Corporation Also Dba Integra Neurosciences |
| 1100 Campus Rd., Princeton, New Jersey, United States, 08540 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77582
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