Neurological Sponges
Brand(s)
Last updated
Summary
Product
Neurological Sponges
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 |
|---|---|---|
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55992C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55994C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55996C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55995C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55997C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 85995C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 85998C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55998C |
| Neurological Sponges | More than 10 numbers, contact manufacturer. | 55993C |
Issue
During an internal review, Medicom has identified the potential for unexpected variability of endotoxin levels on the products. While the products have been demonstrated to consistently meet the endotoxin specification for blood contacting or implantable products, variability has been observed indicating that products in the market potentially may not consistently meet the more stringent endotoxin specification for devices that contact the cerebrospinal fluid.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Amd Medicom Inc.
2555 Chemin De L'Aviation, Montreal, Quebec, Canada, H9P 2Z2
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82100
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