Recall Z-1302-2023 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
Atrium Pneumostat Chest Drain Valve, Part Number 16100
| Date | Mar 30, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction letters dated 3/1/23 were sent to customers. Updated Instructions New Warning and Precautions: The facility can continue use of the product with the IFU that was provided along with the consideration of the following: " NEW and Applicable Existing Warnings and Precautions for Express Mini 500: o NEW Warning: The Express Mini 500 is restricted for use by trained healthcare providers familiar with cardiothoracic surgical procedures and techniques, including the use of chest drains. o NEW Precaution: The Express Mini 500 is restricted for use in a healthcare fa |
| Quantity | 3554 cases of 10 |
| Distribution | Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Colombia, Czech Republic, Germany, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, Israel, Iceland, Italy, Jordan, Sout |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.