Medline Procedure Packs
Brand(s)
Last updated
Summary
Product
Medline Procedure Packs
Issue
Medical devices - Performance
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
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