Atrium Pneumostat Chest Drain Valve, Part Number 16100
Recall
- Recall Number
- Z-2592-2021
- Event Number
- 88446
- Firm
- Atrium Medical Corporation
- FEI Number
- 3011175548
- Product Code
- KDQ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 26, 2021
- Address
- 40 Continental Blvd, Merrimack, NH, 03054-4332
Description
Atrium Pneumostat Chest Drain Valve, Part Number 16100
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
On August 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Atrium/Getinge is in the process of updating the Instructions for Use. In the meantime, the following information was provided: REVISED Indication for Use: Pneumostat is indicated for use with adult patients in a variety of medical conditions in which evacuation of air with or without ancillary fluid is required from the pleural cavity and is also designed to facilitate ambulation. These medical conditions may include pneumothorax, thoracic injury, and other related conditions requiring air evacuation. NEW Contraindication: Not for use in pediatric patients. NEW section for Target Population: The Pneumostat is intended for adult patients who require gravity drainage. NEW Warning: Do not use in situations that require active negative pressure in the pleural space. NEW Precaution: The use of the Pneumostat is restricted to the clinical setting. NEW Precaution: The use of the Pneumostat is restricted to professional healthcare users familiar with thoracic surgical procedures and techniques, including the use of thoracic chest drains. Actions to be taken by Customer: - Please examine your inventory immediately to determine if you have any of the Atrium Pneumostat Chest Drain Valves with the product code 16100. - Please ensure that all Pneumostat Chest Drain Valve users at your facility are aware of this notice and post a copy of the Warning Label included with the letter in all inventory locations within your facility where the Atrium Pneumostat Chest Drain Valves are stored. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Domestic distribution nationwide. Foreign distribution worldwide.
92,430 units