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