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