Health product recall

Disposable Bipolar Pencil 25GA Straight

Last updated

Summary

Product
Disposable Bipolar Pencil 25GA Straight
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Disposable Bipolar Pencil 25GA Straight

More than 10 numbers, contact manufacturer.

14-5011
14-5011L

Issue

Kirwan Surgical Products LLC is conducting a voluntary recall of all 25-gauge Disposable Bipolar Pencils with a sterile lot range from 220906 to 241002 labeled with an expiration date of September 1st, 2027 or later. Serious injury may occur due to the failure mode associated with this recall. One case of serious injury has been reported in which the filament protective sheath came off when the surgeon removed the instrument from the right eye. The sheath stayed in the eye and poked a hole in the retina. Medical intervention prevented permanent damage.

Recall Start Date: November 13, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Obstetrics and gynaecology
Companies

Kirwan Surgical Products, Llc

180 Enterprise Drive, Marshfield, Massachusetts, United States, 02050

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76615

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