Rappel de produits de santé

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

  1. GENTIAN VIOLET/METHYLENE BLUE STANDARD DRESSING
  2. GENTIAN VIOLET/METHYLENE BLUE HEAVY DRAINAGE DRESSING FILM
  3. GENTIAN VIOLET/METHYLENE BLUE DRESSING WITH MOISTURE-RETENTIVE FILM
  4. GENTIAN VIOLET/METHYLENE BLUE TUNNELING DRESSING
  5. 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