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Health product recall

Peristeen Anal Irrigation System (2014-01-15)

Starting date:
January 15, 2014
Posting date:
March 18, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-38315

Recalled Products

Peristeen Anal Irrigation System 

Reason

A Field Safety and Corrective Action (FSCA) outlining updated instructions for use specifically addressing indication, contraindication, precautions, warnings and how to use Peristeen.

Affected products

Peristeen Anal Irrigation System 

Lot or serial number

All lots

Model or catalog number

29121
29126

Companies
Manufacturer
Coloplast A/S
Holtedam 1
Humlebaek
3050
DENMARK