Recall Z-1303-2023— Atrium Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Express Mini 500 Dry Seal Chest Drain, Part Number 16400. 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..
- Recalling firm
- Atrium Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-01
- Firm location
- Merrimack, NH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.