Cardinal Health Cardiovascular, Bypass and Hepatobiliary Packs
Brand(s)
Last updated
Summary
Product
Cardinal Health Cardiovascular, Bypass and Hepatobiliary Packs
Issue
Medical devices - Sterility
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 |
|---|---|---|
| General Cardiovascular Pack | 190859 | SCV30CAMUO |
| Bypass (Pontage) Packs | 936109 85590 | PV30CAS13 PV30CASCB |
| Hepatobiliary Pack | 36786 22704 | SBA30HBHSI |
Issue
The recent expansion to medical device recall from Medtronic/Covidien concerning various sutures found in some Cardinal Health Presource® kits. Specific lots of these sutures were sterilized with gamma doses that exceed the range approved or were exposed to more than the approved number of ethylene oxide (EO) sterilization cycles.
Recall Start Date: February 29, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Companies
Cardinal Health
3651 Birchwood Drive, Waukegan, Illinois, United States, 60085
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75220
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