Integra Cranial Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Cranial Kit - No Drugs |
7275713 |
INS-5HND |
Issue
The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect (potential holes and tears) in the sterile packaging (header bag) of the cranial access kit which creates a potential sterility concern. The header bag represents the sterile barrier for the cranial access kit, which is sold as a single use, sterile kit.
Recall start date: May 1, 2024
Additional information
Details
Integra Pain Management
3498 West 2400 South #1050, West Valley City, Utah, United States, 84119
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