Chest Drain Valve Recalled for Insufficient Safety Instructions
The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II with instruction deficiencies for a risk-of-harm medical device. No reported illnesses or injuries. Per rubric: risk-of-harm products without reported injury score as High.
Plain-English summary
The Atrium Pneumostat Chest Drain Valve, Part Number 16100, manufactured by Atrium Medical Corporation, is being recalled due to insufficient instructions for safe use.
The device's Instructions for Use do not contain adequate precautions against continuing to use the valve when it should be drained for discontinuation, nor do they provide sufficient warnings against using the device outside of healthcare settings. These instruction gaps create a risk of improper use.
The recall affects 3,554 cases distributed worldwide, including the US and 39 other countries. All lots manufactured within 3 years prior to the correction initiation are affected.
Patients and healthcare providers should consult with Atrium Medical Corporation for corrected instructions and guidance on safe use of this device.
The recalled product
- Product
- Atrium Pneumostat Chest Drain Valve, Part Number 16100
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 20650862161001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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