Acufex Access Advanced Positioning Kits
Last updated
Summary
Product
Acufex Access Advanced Positioning Kits
Issue
Medical devices - Sterility Issue
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Acufex Access Advanced Positioning Kits | 50971615 | 72205104 |
| Acufex Access Advanced Positioning Kits | 50971617 | 72205104 |
| Acufex Access Advanced Positioning Kits | 5096788 | 72205104 |
Issue
Smith & Nephew, Inc., has initiated a field action to voluntarily remove three lots of the Acufex Access Advanced Positioning Kits due to the sterilization omission. The affected products were inadvertently shipped to the global distribution center instead of the sterilizer and therefore it did not undergo the applicable sterilization process.
Recall start date: December 14, 2021
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
| Smith & Nephew, Inc., Endoscopy Division |
|
150 Minuteman Road, Andover, Massachusetts United States, 01810 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63750
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