CanadaAmd Medicom Inc. Neurological Sponges (catalogue numbers 55992C, 55994C, 55996C, 55995C, 55997C, 85995C, 85998C, 55998C, 55993C; lot/serial numbers are listed as more than 10 numbers — contact the manufacturer) are affected. An internal review identified potential unexpected variability of endotoxin levels that, although products meet the endotoxin specification for blood-contacting or implantable products, may not consistently meet the more stringent specification for devices contacting cerebrospinal fluid. Contact the manufacturer for additional information.
What's being recalled
Companies: Amd Medicom Inc., 2555 Chemin De L'Aviation, Montreal, Quebec, Canada, H9P 2Z2.
How to identify it
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55992C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55994C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55996C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55995C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55997C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 85995C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 85998C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55998C
Affected products: Neurological Sponges; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 55993C
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
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