CanadaCardinal Health Cardiac Electrophysiology (EP) Packs (model/catalogue SAN30EP'XXX', lot numbers 479584 and 473022) are affected. The recall was issued because the Namic Angiographic Control Syringe rotating adaptor may unwind during use, which can cause a loose connection or full disconnection between the syringe and manifold; Presource determined some kits may contain the affected Medline component and lot numbers. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Cardinal Health 200, LLC Also Trading As Cardinal Health, 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085.
How to identify it
Affected products: Cardiac Electrophysiology (EP) Packs; Lot or serial number: 479584; Model or catalogue number: SAN30EP'XXX'
Affected products: Cardiac Electrophysiology (EP) Packs; Lot or serial number: 473022; Model or catalogue number: SAN30EP'XXX'
The hazard
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).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)