Recall MonitorHealth Products
Neurological Sponges
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Neurological Sponges
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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.