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