Health product recall

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