GENTIAN VIOLET/METHYLENE BLUE DRESSING SYSTEM (2019-07-17)
- Starting date:
- July 17, 2019
- Posting date:
- July 26, 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-70535
Last updated: 2019-07-26
Affected Products
- GENTIAN VIOLET/METHYLENE BLUE STANDARD DRESSING
- GENTIAN VIOLET/METHYLENE BLUE HEAVY DRAINAGE DRESSING FILM
- GENTIAN VIOLET/METHYLENE BLUE DRESSING WITH MOISTURE-RETENTIVE FILM
- GENTIAN VIOLET/METHYLENE BLUE TUNNELING DRESSING
- HYDROFERA BLUE READY ANTIBACTERIAL FOAM DRESSING
Reason
Update to instructions for use which are safety related clarifications aimed at better informing users in response to the Health Canada Advisory related to Gentian Violet issued on June 12, 2019
Affected products
A. GENTIAN VIOLET/METHYLENE BLUE STANDARD DRESSING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HB2214
HB4414
HB6614
Companies
- Manufacturer
-
Hydrofera, LLC.
340 Progress Drive
Manchester
06042
Connecticut
UNITED STATES
B. GENTIAN VIOLET/METHYLENE BLUE HEAVY DRAINAGE DRESSING FILM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HBHD4450
HBHD6675
Companies
- Manufacturer
-
Hydrofera, LLC.
340 Progress Drive
Manchester
06042
Connecticut
UNITED STATES
C. GENTIAN VIOLET/METHYLENE BLUE DRESSING WITH MOISTURE-RETENTIVE FILM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HBRF2258
HBRF2650
HBRF4414
HBRF4475
Companies
- Manufacturer
-
Hydrofera, LLC.
340 Progress Drive
Manchester
06042
Connecticut
UNITED STATES
D. GENTIAN VIOLET/METHYLENE BLUE TUNNELING DRESSING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HBT0906
Companies
- Manufacturer
-
Hydrofera, LLC.
340 Progress Drive
Manchester
06042
Connecticut
UNITED STATES
E. HYDROFERA BLUE READY ANTIBACTERIAL FOAM DRESSING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
HBRS2520
HBRS4520
HBRS8820
Companies
- Manufacturer
-
Hydrofera, LLC.
340 Progress Drive
Manchester
06042
Connecticut
UNITED STATES