Rappel de produits de santé

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

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

LIGAMAX Endoscopic Multiple Clip Applier with Clips

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

EL5ML

Companies
Manufacturer
Ethicon Endo-Surgery, LLC
475 CALLE C
GUAYNABO
00969
PUERTO RICO