# Major Recall Alert: Altitude™, Aqua-Seal™, Argyle™, Sentinel Seal™, and Thora-Seal™ Chest Drainage Units Updated for Intended Use in Adults Aged 18+
Cardinal Health has announced an important recall pertaining to its chest drainage units (CDUs) and accessories. This recall serves to notify customers about updates to the instructions for use (IFUs), which clarify the intended target patient population for these devices. The affected CDUs are specified for use in adults, 18 years and older. If you or a healthcare provider you know uses these units, it’s critical to take action to ensure safety and proper usage.
## Why This Recall is Important
Chest drainage units play a vital role in medical procedures, particularly for patients recovering from thoracic surgeries, trauma, or lung issues. Ensuring accurate and clear instructions for use is crucial to avoid potential safety risks or improper applications. Cardinal Health identified the need to revise the intended patient demographic for the devices, ensuring they are exclusively recommended for adult patients aged 18 and older.
This clarification helps to prevent any potential misuse of these devices on pediatric or adolescent patients, which could lead to risks, complications, or an unintended lack of efficacy. While no injuries or adverse events have been reported related to this update, it’s essential for all users to follow the revised guidelines.
## Details of the Recall
The recall specifically affects several Cardinal Health chest drainage units and replacement chamber systems. Below is a list of the impacted models:
- **Altitude™ Dry Suction Chest Drainage Unit (Autotransfusion-Ready)**
- **Aqua-Seal™ Chest Drainage Unit, Wet Suction**
- **Argyle™ Thora-Seal™ Chest Drainage Unit Three Chamber**
- **Sentinel Seal™ Chest Drainage Unit**
- **Thora-Seal™ 1 Chest Drainage Unit**
- **Thora-Seal™ Replacement Collection Chamber Three Chamber System 2500 mL**
### Recall Reason:
The instructions for use (IFUs) have been updated to clarify that these listed devices are intended only for adult patients aged 18 years or older. This update ensures safe and appropriate application in clinical settings.
### Announced Date:
This recall was officially announced on **October 31, 2023**.
## What You Should Do
If you or your healthcare facility uses Cardinal Health chest drainage units, here are the steps you should follow:
- **Review Updates:** Download and carefully review the updated instructions for use (IFUs) for the specified models to ensure a clear understanding of the target patient population.
- **Stop Pediatric Use:** Immediately cease the use of these devices on patients under the age of 18.
- **Notify Staff:** Inform all relevant team members, healthcare providers, and caregivers about this recall and the updated guidelines for adult use only.
- **Contact Cardinal Health:** Reach out to Cardinal Health customer support if you have further questions or need assistance with replacement parts or updated instructions.
For more details about this recall, visit the official recall notice provided by Health Canada here: [Cardinal Health Recall Official Source](https://recalls-rappels.canada.ca/en/alert-recall/cardinal-healthtm-chest-drain-units-and-accessories).
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**Stay informed, stay safe, and take action today.**