Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Reported: April 5, 2023 Initiated: March 1, 2023 #Z-1303-2023
Product Description
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
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. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 8184 cases of 6
- 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, South Korea, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Portugal, Sweden, Singapore, Slovenia, Thailand.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Express Mini 500 Dry Seal Chest Drain, Part Number 16400. Recalled by Atrium Medical Corporation. Units affected: 8184 cases of 6.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1303-2023.
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