Neurological Sponges
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Amd Medicom Inc.
2555 Chemin De L'Aviation, Montreal, Quebec, Canada, H9P 2Z2
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