# Major Recall Alert: Hemodialysis Opening (Hemodialyse Ouverture) Packs Recalled Due to Tego™ Silicone Seal Issues
A major recall has been announced affecting Hemodialysis Opening (Hemodialyse Ouverture) Packs due to concerns with the Tego™ silicone seal. Cardinal Health recently informed customers that ICU Medical Inc. has issued this recall due to lot-specific issues with the silicone seal used in the Tego device. For those relying on these essential medical products for hemodialysis care, knowing the details and recommended actions is critical to ensure your safety.
## Why This Recall is Important
Medical devices like the Hemodialysis Opening Packs play a crucial role in providing life-saving care. Unfortunately, this recall highlights a potential risk associated with the silicone seal in the Tego component of the device. Compromised silicone seals may impact the safety and functionality of the product, potentially leading to complications in medical treatments. Ensuring patient safety is the top priority, which is why ICU Medical and Cardinal Health are urging customers to take immediate action.
Issues with medical device performance can pose serious health risks. In this case, ICU Medical identified the problem as specific to certain product lots, but exact details about the risks have not been disclosed. Patients, healthcare providers, and caregivers should stay informed and act promptly to minimize any potential harm.
## Details of the Recall
Here’s what you need to know about the Hemodialysis Opening (Hemodialyse Ouverture) Packs recall:
- **Category**: Medical Device Recall
- **Brand**: Hemodialysis Opening (Hemodialyse Ouverture) Packs
- **Product Affected**: Hemodialysis Opening (Hemodialyse Ouverture) Packs
- **Recall Reason**: Lot-specific issues involving the Tego™ silicone seal
- **Date Announced**: October 2023
- **Company Involved**: ICU Medical Inc., with Cardinal Health facilitating the notification.
For the complete recall notice, visit the official government link: [Canada Recall Notice for Hemodialysis Opening Packs](https://recalls-rappels.canada.ca/en/alert-recall/hemodialysis-opening-hemodialyse-ouverture-packs).
## What You Should Do
If you or someone you know is using the recalled Hemodialysis Opening (Hemodialyse Ouverture) Packs, follow these steps immediately:
- **Check Lot Numbers**: Contact Cardinal Health or your medical supplier for information about affected lot numbers.
- **Contact Your Healthcare Provider**: Notify your dialysis center, doctor, or caregiver about the recall to determine alternative options.
- **Report Any Issues**: If you notice any irregularities with the device, report them to your healthcare provider right away.
- **Dispose of Recalled Products**: Safely discontinue use of the affected products and replace them with unaffected alternatives.
If you have further questions or concerns, contact ICU Medical Inc. or visit their website for additional information.
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For more details about this recall, refer to the official announcement: [Hemodialysis Opening (Hemodialyse Ouverture) Packs Recall](https://recalls-rappels.canada.ca/en/alert-recall/hemodialysis-opening-hemodialyse-ouverture-packs).