Microtek Decanter Devices
Last updated
Summary
Product
Microtek Decanter Devices
Issue
Medical devices - Sterility
Medical devices - Unauthorised device
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Transfer Device | 170828 231027 | 2008S |
| Vial Decanter | 231230 180620 | 2006S |
| Bottle Decanter | 180625 221220 | 2004S |
| C-Flo Bag Decanter | 180122 240110 | 2000S |
| Bag Decanter II | 240219 170216 | 2002S |
Issue
During sterile barrier testing performed on the decanter product line the samples were identified to have pin holes and tears in the packaging film. Furthermore, the specified decanter devices were not licensed in accordance with Canadian Medical Devices Regulations.
Recall start date: May 24, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Microtek Medical, Inc. (An Ecolab Company)
1 Ecolab Place, St. Paul, Minnesota, United States, 55102
Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-75665
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