No image published for this recall

No image published for this recall

Soltive™ superpulsed laser ball tip fiber single use

Official notice

4 Jan 2024

Last checked

4 Jan 2024

Medium riskHealth Canada

An official Health Canada notice concerns Soltive™ superpulsed laser ball tip fiber single use. Olympus (Gyrus ACMI, Inc.) is initiating a recall and advising customers of the potential for a breached sterile pouch seal on the 200 Micron TFL ball tip single-use soltive laser fiber. Olympus has received one (1) complaint regarding a breach of the TFL-FBX200BS laser fiber pouch seal. Initial investigation shows this to be an isolated event. Recall start date: December 12, 2023 Published 2024-01-04.

What to do now

Review notice, cease use/quarantine and return affected product, complete/return online response form.

Recall number

74846

Official notice

2024-01-04

The hazard

Olympus (Gyrus ACMI, Inc.) is initiating a recall and advising customers of the potential for a breached sterile pouch seal on the 200 Micron TFL ball tip single-use soltive laser fiber. Olympus has received one (1) complaint regarding a breach of the TFL-FBX200BS laser fiber pouch seal. Initial investigation shows this to be an isolated event. Recall start date: December 12, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74846

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Affected products

Product 1

Affected products - SOLTIVE™ SuperPulsed Laser Ball Tip Fiber Single Use, Lot or serial number - KR262848, Model or catalog number - TFL-FBX200BS

Risk / hazard

Olympus (Gyrus ACMI, Inc.) is initiating a recall and advising customers of the potential for a breached sterile pouch seal on the 200 Micron TFL ball tip single-use soltive laser fiber. Olympus has received one (1) complaint regarding a breach of the TFL-FBX200BS laser fiber pouch seal. Initial investigation shows this to be an isolated event. Recall start date: December 12, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Soltive™ Superpulsed Laser Ball Tip Fiber Single Use.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74846

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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