Monoject Bluntfill with Filter, Hypodermic Safety Needle & 3 Ml Syringe with Hypodermic Safety Needle (2020-01-23)
- Starting date:
- January 23, 2020
- Posting date:
- February 21, 2020
- 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-72369
Last updated: 2020-02-21
Affected Products
- Monoject Bluntfill with Filter
- Monoject Hypodermic Safety Needle
- Monoject 3 Ml Syringe with Hypodermic Safety Needle
Reason
This recall is being conducted due to non-sterile product that was inadvertently shipped to customers. The product is labeled as "NON-STERILR Not For Human Use" (Exhibit A). The usage of a needle that is not sterile could result in infection. The recall is being initiated on January 22, 2020.
Affected products
A. Monoject Bluntfill with Filter
Lot or serial number
15072024
Model or catalog number
11811022F
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 Hypodermic Safety Needle
Lot or serial number
- 15063001
- 15063004
Model or catalog number
- 1182558
- 1183005
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. Monoject 3 Ml Syringe with Hypodermic Safety Needle
Lot or serial number
15072015
Model or catalog number
11832215
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES