LIGAMAX Endoscopic Multiple Clip Applier with Clips (2019-11-07)

Starting date:

November 7, 2019

Posting date:

November 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71738

Last updated: 2019-12-02

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  Reason
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  Affected products

Affected Products

LIGAMAX Endoscopic Multiple Clip Applier with Clips

Reason

The potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the tyvek lidding which could result in a breach of sterility. In the event that the sterility barrier has been breached, there is a chance that a pathogen may be introduced and if unrecognized or untreated may cause life threatening infection. As the population at risk is most likely to receive prophylactic antibiotics the probability of harm is extremely rare.

Affected products