CanadaThe affected products are Cardinal Health chest drainage units and accessories: Thora‑Seal 1 Chest Drainage Unit (model 8884713100), Argyle Thora‑Seal Chest Drainage Unit Three Chamber (8884713308), Thora‑Seal Replacement Collection Chamber 2500 mL (8884713900), Aqua‑Seal Chest Drainage Unit Wet Suction (8888571299), Sentinel Seal Chest Drainage Unit (8888571562), and Altitude Dry Suction Chest Drainage Unit (autotransfusion‑ready) (8888571370); all lots. The instructions for use have been updated to clarify the intended target patient population as adults 18 years and older. 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: Thora-Seal™ 1 Chest Drainage Unit; Lot or serial number: All lots.; Model or catalogue number: 8884713100
Affected products: Argyle™ Thora-Seal™ Chest Drainage Unit Three Chamber; Lot or serial number: All lots.; Model or catalogue number: 8884713308
Affected products: Thora-Seal™ Replacement Collection Chamber Three Chamber System 2500 mL; Lot or serial number: All lots.; Model or catalogue number: 8884713900
Affected products: Aqua-Seal™ Chest Drainage Unit, Wet Suction; Lot or serial number: All lots.; Model or catalogue number: 8888571299
Affected products: Sentinel Seal™ Chest Drainage Unit; Lot or serial number: All lots.; Model or catalogue number: 8888571562
Affected products: Altitude™ Dry Suction Chest Drainage Unit (Autotransfusion-Ready); Lot or serial number: All lots.; Model or catalogue number: 8888571370
The hazard
The purpose of this action is to communicate to customers that the instructions for use (IFUs) on the listed Cardinal Health Chest Drainage Units (CDUs) and Accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
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)