CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

Atrium Pneumostat Chest Drain Valve recalled by Atrium Medical

Atrium Medical is recalling Atrium Pneumostat Chest Drain Valve, distributed nationwide in the US. The recall was initiated on 1 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 20650862161001; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 453404 455900 458299 464069 455901 454344 448618 449703 449992 449993 450923 450924 451439 452012 452013 452575 453404 453472 454260 454344 454345 454589 454803 454850 454851 455359 455360 455370 455898 455900 455901 456447 456448 456904 456905 458298 458299 458300 458301 458642 458643 458644 458645 461545 463439 463441 463442 463443 463469 463586 463587 464069 464103 464104 464105 464669 464809 465368

Quantity recalled3554 cases of 10

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-1302-2023
FDA event ID: 91718
Recalling firm: Atrium Medical, Merrimack, NH
Classification: Class II
Status: Ongoing
Recall initiated: 1 Mar 2023
FDA classified: 30 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

1 Mar 2023	Recall initiated by company
30 Mar 2023	Classified by FDA	+29 days
5 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Where it was distributed

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.

Nationwide

Questions about this recall

Is Atrium Pneumostat Chest Drain Valve recalled?

Yes. Atrium Medical recalled Atrium Pneumostat Chest Drain Valve on 1 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1302-2023.

Why was it recalled?

Which lots are affected?

UDI-DI: 20650862161001; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 453404 455900 458299 464069 455901 454344 448618 449703 449992 449993 450923 450924 451439 452012 452013 452575 453404 453472 454260 454344 454345 454589 454803 454850 454851 455359 455360 455370 455898 455900 455901 456447 456448 456904 456905 458298 458299 458300 458301 458642 458643 458644 458645 461545 463439 463441 463442 463443 463469 463586 463587 464069 464103 464104 464105 464669 464809 465368

Where was it sold?

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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