Health product recall

Monoject Blunt Cannula, Monoject Standard Hypodermic Needles (2019-04-28)

Starting date:
April 28, 2019
Posting date:
May 10, 2019
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-69888

Last updated: 2019-05-10

Affected Products

  1. Monoject Blunt Cannula
  2. Monoject Standard Hypodermic Needles

Reason

Cardinal Health is voluntarily recalling specific production lots of Monoject Standard Hypodermic Needles, Vet Pak Hypodermic Needles and blunt cannulas. The products were distributed between January 28, 2019 and April 23, 2019. This recall is being conducted due to a manufacturing defect that was found for the cartridge component, which could compromise the sterility barrier of the product. The usage of a needle with compromised sterility could result in infection. Cardinal Health is not aware of any reports of patient harm.

Affected products

A. Monoject Blunt Cannula

Lot or serial number
  • 902110
  • 902111
  • 903530
  • 905617
  • 905618
  • 905619
  • 905620
  • 905659
  • 905660
  • 906343
  • 907004
  • 907005
  • 907734
Model or catalog number
  • 8881202314
  • 8881202322
  • 8881202355
  • 8881202363
  • 8881202389
Companies
Manufacturer

Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES

B. Monoject Standard Hypodermic Needles

Lot or serial number
  • 904212
  • 904218
  • 904901
  • 904918
  • 904956
  • 905612
  • 905613
  • 906329
  • 907002
  • 907007
Model or catalog number
  • 8881200011
  • 8881200029
  • 8881200037
  • 8881200045
  • 8881200078
  • 8881200508
Companies
Manufacturer

Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES