HALO PKS Cutting Forceps
Brand(s)
Last updated
Summary
Product
HALO PKS Cutting Forceps
Issue
Medical devices - Performance
What to do
OLYMPUS CANADA INC. TO RECALL.CANADA@OLYMPUS.COM
Audience
Healthcare
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| HALO PKS Cutting Forceps | More than 10 numbers, contact manufacturer. | PK-CF0533 |
Issue
Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023.
Recall Start Date: January 19, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74987
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