Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing, and LogiCal Kits (2021-03-26)
- Starting date:
- March 26, 2021
- Posting date:
- April 8, 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-75339
Last updated:
2021-04-08
Affected Products
A. HIGH PRESSURE ROTATOR WITH MALE LUER LOCK 50/CA
B. STOPCOCKS
C. LOGICAL@3 GANG MANIFOLD 1/EA
Reason
Smiths Medical became awarethatspecific lots of Medex® High PressureAdaptors, Rotators, Manifolds,Stopcocks and Tubing and Medex®LogiCal® Kits may have beenmanufactured with insufficient orincomplete welds. Devices with aninsufficient or incomplete weld maypotentially fail during use.
Affected products
A. HIGH PRESSURE ROTATOR WITH MALE LUER LOCK 50/CA
Lot or serial number
3952480
3974771
Model or catalog number
MX496HP
Companies
- Manufacturer
-
Smiths Medical ASD Inc.
6250 Shier Rings Rd
Dublin, Ohio
43016
Ohio
UNITED STATES
B. STOPCOCKS
Lot or serial number
3971467
3987918
3995545
Model or catalog number
MX1431MRL
MX4331R
Companies
- Manufacturer
-
Smiths Medical ASD Inc.
6250 Shier Rings Rd
Dublin, Ohio
43016
Ohio
UNITED STATES
C. LOGICAL@3 GANG MANIFOLD 1/EA
Lot or serial number
4042461
Model or catalog number
M20178R2
Companies
- Manufacturer
-
Smiths Medical ASD Inc.
6250 Shier Rings Rd
Dublin, Ohio
43016
Ohio
UNITED STATES