Kerlix 100% Bandage Cotton Large, Kerlix AMD Antimicrobial Large Roll, DERMACEA Fluff Roll, and Kerlix Gauze Large Roll (2018-08-07)
- Starting date:
- August 7, 2018
- Posting date:
- October 19, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67872
Affected products
A. Kerlix 100% Bandage Cotton Large
B. Kerlix AMD Antimicrobial Large Roll
C. DERMACEA Fluff Roll, 6 Ply, 4.5 Inch x 4.1 yd, Stretched, Sterile
D. Kerlix Gauze Large Roll
Reason
This voluntary recall is being conducted due to a small percentage of product has the potential to have an open seal or a pinched seal defect in the primary flexible sealed pouches, which could result in a sterility breach of the product. Use of product containing this type of seal defect may lead to infection due to potential break in the sterile barrier.
Affected products
A. Kerlix 100% Bandage Cotton Large
Lot or serial number
18E071762
18E072262
18E072362
18E132262
18E132362
Model or catalog number
6716
Companies
- Manufacturer
-
Cardinal Health
Patient Recovery Business from Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. Kerlix AMD Antimicrobial Large Roll
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
3332
Companies
- Manufacturer
-
Cardinal Health
Patient Recovery Business from Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. DERMACEA Fluff Roll, 6 Ply, 4.5 Inch x 4.1 yd, Stretched, Sterile
Lot or serial number
18F072462
18F122362
18F122462
Model or catalog number
441103
Companies
- Manufacturer
-
Cardinal Health
Patient Recovery Business from Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
D. Kerlix Gauze Large Roll
Lot or serial number
18E030462
18E223262
18F122962
Model or catalog number
7880
Companies
- Manufacturer
-
Cardinal Health
Patient Recovery Business from Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES