Atrium Medical Corporation: Medical Device Recall in 2023 - (Recall #: Z-1302-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Product Classification:

Class II

Date Initiated: March 1, 2023

Date Posted: April 5, 2023

Recall Number: Z-1302-2023

Event ID: 91718

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.

Status: Ongoing

Product Quantity: 3554 cases of 10

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated