Cardinal Health EP Packs Type I Recall

Health Canada Recalls & Safety Alerts

Filed March 27th, 2026

Detected March 30th, 2026

Summary

Health Canada issued a Type I medical device recall for Cardinal Health Cardiac Electrophysiology (EP) Packs containing potentially affected Medline Namic Angiographic Control Syringes. The recall addresses a risk that the syringe rotating adaptor may unwind during use, causing loose connection or full disconnection between the syringe and manifold. Affected products include lots 479584 and 473022 with model number SAN30EP'XXX'.

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What changed

Health Canada has issued a Type I recall (the most serious classification) for Cardinal Health Cardiac Electrophysiology (EP) Packs containing Medline Industries Namic Angiographic Control Syringes. The recall affects lots 479584 and 473022, model SAN30EP'XXX'. The underlying issue is that the syringe rotating adaptor may unwind during procedures, resulting in a loose connection or complete disconnection between the syringe and manifold. Cardinal Health's Presource investigation determined that customers may have received kits containing the affected Medline component(s) and lot number(s).

Healthcare providers and medical facilities that have Cardinal Health Cardiac EP Packs in stock or in use must immediately identify affected products by lot number and model, stop using the affected devices, and contact Cardinal Health for return or replacement instructions. Manufacturers and distributors in the supply chain should verify whether any products contain the affected Medline syringe component. Failure to address affected devices poses serious patient safety risks including potential air embolism or inaccurate diagnostic measurements.

What to do next

Identify Cardinal Health Cardiac EP Packs (SAN30EP'XXX') in inventory or use, specifically checking for lot numbers 479584 and 473022
Remove affected devices from service immediately and contact Cardinal Health for return or replacement instructions
Notify relevant clinical staff and review patient safety protocols if affected products were used in procedures

Source document (simplified)

Health product recall

Cardinal Health Cardiac Electrophysiology (EP) Packs

Brand(s)

Cardinal Health 200, Llc Also Trading As Cardinal Health

Last updated

2026-03-30

Summary

Product Cardinal Health Cardiac Electrophysiology (EP) Packs Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare Industry

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Cardiac Electrophysiology (EP) Packs | 479584 | SAN30EP'XXX' |
| Cardiac Electrophysiology (EP) Packs | 473022 | SAN30EP'XXX' |

Issue

Cardinal Health was recently informed of a medical device recall from Medline Industries. Concerning the Namic Angiographic Control Syringes referenced. The recall is being issued due to a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Presource has completed its investigation regarding the recall and determined that customers may have received Presource kits containing the affected Medline industries component(s) and lot number(s).

Additional information

Details

Original published date:

2026-03-30

Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies Cardinal Health 200, LLC Also Trading As Cardinal Health

3651 Birchwood Drive, Waukegan, Illinois, United States, 60085

Published by Health Canada Audience Healthcare Industry Recall class Type I Recall date

2026-03-27

Identification number RA-81803