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Peristeen Anal Irrigation System, Catheter and Irrigation Accessory Unit (2014-01-15)
- Starting date:
- January 15, 2014
- Posting date:
- March 25, 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-38547
Recalled Products
A. Peristeen Anal Irrigation System
B. Peristeen Anal Irrigation Rectal Catheter
C. Peristeen Anal Irrigation Accessory Unit
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
A. Peristeen Anal Irrigation System
Lot or serial number
29121
29126
Model or catalog number
All lots
Companies
- Manufacturer
-
Coloplast A/S
Holtedam 1
Humlebaek
3050
DENMARK
B. Peristeen Anal Irrigation Rectal Catheter
Lot or serial number
29123
Model or catalog number
All lots
Companies
- Manufacturer
-
Coloplast A/S
Holtedam 1
Humlebaek
3050
DENMARK
C. Peristeen Anal Irrigation Accessory Unit
Lot or serial number
29122
Model or catalog number
All lots
Companies
- Manufacturer
-
Coloplast A/S
Holtedam 1
Humlebaek
3050
DENMARK