Health product recall

AirLife Arterial Blood Gas (ABG) Sampling Syringes, Aspirators and Kits (2018-04-23)

Starting date:
April 23, 2018
Posting date:
May 18, 2018
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-66798

Affected products

A. ABG KIT - ASPIRATOR WITH ALCOHOL PREP PAD AND GAUZE
B. ABG KIT - ASPIRATOR, NEEDLE, ALCOHOL PAD, GAUZE AND BANDAID
C. ABG KIT, BLOOD SAMPLER W/ CHG-ALCOHOL SWAB, GAUZE, ICE BAG

Reason

Trudell Medical Marketing Limited (TMML) initiated a Field Correction Notice involving the AirLife Arterial Blood Gas (ABG) sampling syringes, aspirators and kits manufactured by Vyaire Medical.
This Field Correction Notice is being issued as a result of the Field Correction Notice issued by Vyaire Medical, the manufacturer of the ABG sampling syringes used in TMML's ABG Kits. As informed by Vyaire Medical an error in labeling occurred where the incorrect statement "LUER SLIP" was printed as part of the product description for various ABG sampling syringes, aspirators and kits that contain the luer lock syringe type.

Affected products

A. ABG KIT - ASPIRATOR WITH ALCOHOL PREP PAD AND GAUZE

Lot or serial number

1802895

Model or catalog number

M02P4023LTRUMU

Companies
Manufacturer
Trudell Medical Marketing Limited
758 Third St
London
N5V 5J7
Ontario
CANADA

B. ABG KIT - ASPIRATOR, NEEDLE, ALCOHOL PAD, GAUZE AND BANDAID

Lot or serial number

1602685
1602697
1802910

Model or catalog number

M02P4023ECHD

Companies
Manufacturer
Trudell Medical Marketing Limited
758 Third St
London
N5V 5J7
Ontario
CANADA

C. ABG KIT, BLOOD SAMPLER W/ CHG-ALCOHOL SWAB, GAUZE, ICE BAG

Lot or serial number

1602653
1702718
1702759
1702793
1702813
1702846
1702872
1802921

Model or catalog number

M024023EC10106

Companies
Manufacturer
Trudell Medical Marketing Limited
758 Third St
London
N5V 5J7
Ontario
CANADA