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

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