Health product recall

Microtek Decenter Devices

Last updated

Summary

Product
Microtek Decenter Devices
Issue
Medical devices - Sterility Issue
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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