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
- Monoject Blunt Cannula
- 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