Health product recall

Smiths Medical Rotators

Last updated

Summary

Product
Smiths Medical Rotators
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Rotating Adaptors 4330826 4384397 MX497HP
700PSI Stopcock W/ Rotator 4355397 4380735 4387234 MX433-1R
48in (121.9cm) Injection Line Rotating Adapt (900PSI) 4404698 4371082 4398429 4383431 4387987 MX694R
Pressure Transducers 4387983 4383385 4392487 MX20449 M20178R2

Issue

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity.

Recall Start Date: November 9, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - General hospital and personal use
Companies

Smiths Medical Asd, Inc.

6250 Shier Rings Rd, Dublin, Ohio, United States, 43016

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74658