Health product recall

Fistula Wound Crown, Fistula Funnel, Isolator Strip (2019-01-25)

Starting date:
January 25, 2019
Posting date:
February 15, 2019
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-69036

Affected Products

  • A. Wound Crown
  • B. Fistula Funnel
  • C. Isolator Strip

Reason

Recall due to re-classification of medical devices from Class I to Class II.

Affected products

A. Wound Crown

Lot or serial number

Contact manufaturer.

Model or catalog number

00860013000332.S

Companies
Manufacturer
Fistula Solution Corporation
10604 230th Street North
Scandia
55073
Minnesota
UNITED STATES

B. Fistula Funnel

Lot or serial number

Contact manufacturer.

Model or catalog number

00860013000356.S

Companies
Manufacturer
Fistula Solution Corporation
10604 230th Street North
Scandia
55073
Minnesota
UNITED STATES

C. Isolator Strip

Lot or serial number

Contact manufacturer.

Model or catalog number

00860013000349.S

Companies
Manufacturer
Fistula Solution Corporation
10604 230th Street North
Scandia
55073
Minnesota
UNITED STATES