Z-1302-2023 Class II Ongoing
FDA device recall Z-1302-2023 was initiated by Atrium Medical Corporation on March 1, 2023 and is designated Class II. Reason for recall: 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. A… The recall status is ongoing. Affected quantity: 3554 cases of 10.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3554 cases of 10
Product Description
Reason for Recall
Distribution Pattern
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, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.