TRACKABLE SUCTION-SUCTION SET (2021-04-22)
- Starting date:
- April 22, 2021
- Posting date:
- May 13, 2021
- 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-75567
Last updated:
2021-05-13
Affected Products
A. TRACKABLE SUCTION-SUCTION SET STANDARD
B. TRACKABLE SUCTION-SUCTION SET MALLEABLE
Reason
After an in-house inspection on a selection of suction tubes, multiple samples were identified with visible burrs/metal filings affixed along the suction tube inner perimeter. Further investigation has determined that the defect is related to a deficiency in the supplier production process.
Affected products
A. TRACKABLE SUCTION-SUCTION SET STANDARD
Lot or serial number
Not applicable.
Model or catalog number
SYN-0657
Companies
- Manufacturer
-
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto
M5V 3B1
Ontario
CANADA
B. TRACKABLE SUCTION-SUCTION SET MALLEABLE
Lot or serial number
Not applicable.
Model or catalog number
SYN-0783
Companies
- Manufacturer
-
Synaptive Medical Inc.
555 Richmond Street West, Suite 800
Toronto
M5V 3B1
Ontario
CANADA