CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
16400 Express Mini 500 dry seal drain recalled by Atrium Medical
Atrium Medical is recalling Atrium Medical 16400 Express Mini 500 dry seal drain, distributed nationwide in the US. The recall was initiated on 29 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1088-2017
- FDA event ID
- 75599
- Recalling firm
- Atrium Medical, Hudson, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2016
- FDA classified
- 24 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 29 Nov 2016 | Recall initiated by company | |
| 24 Jan 2017 | Classified by FDA | +56 days |
| 1 Feb 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Outer Packaging is not sterile
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
Questions about this recall
Is 16400 Express Mini 500 dry seal drain recalled?
Yes. Atrium Medical recalled 16400 Express Mini 500 dry seal drain on 29 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-1088-2017.
Why was it recalled?
Outer Packaging is not sterile
Which lots are affected?
All Lot Numbers With Expiration Date Prior To October 2019
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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