Health product recall

Medline Procedure Packs

Last updated

Summary

Product
Medline Procedure Packs
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
Cath Radial SHSC-LF 23GBH046 23DBJ368 23EBG844 23FBC429 DYNJ46787D
Cardiac Cath SHSC-LF 23DBH639 23FBH385 DYNJ46788D

Issue

This recall has been issued due to a potential defect with non-sterile high-pressure rotators (catalog#: b14331r) affecting specific rotator lots within Medline packs. The inner diameter of the device's o-ring may be oversized affecting seal integrity.

Recall start date: January 19, 2024

Additional information

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

Medline Industries, LP

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75051