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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91718

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 01, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Atrium Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Z-1302-2023
Recall number
Z-1302-2023
Initiated
March 01, 2023
Classification
Class II
Status
Ongoing
Quantity
3554 cases of 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 2 of 2

Express Mini 500 Dry Seal Chest Drain, Part Number 16400

Z-1303-2023
Recall number
Z-1303-2023
Initiated
March 01, 2023
Classification
Class II
Status
Ongoing
Quantity
8184 cases of 6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI-DI: 00650862164008; All lots manufactured 3 years prior to correction initiation: Lot Numbers: 477059 478375 481999 483536 484044 485782 486195 477059 478375 481105 485782 449700 450921 451436 460632 463584 463585 464668 472965 472969 473749 477059 445024 448992 449700 449990 450921 450922 451436 452010 452011 452574 453402 460620 460621 460629 460630 460631 460632 460633 460787 461043 461333 461336 461337 461821 461822 461823 461824 461940 462215 462487 462489 463584 463585 464101 464102 464667 464668 465132 465138 465516 465517 465667 465668 472838 472965 472966 472969 473749 475492 477059 477985 475492 477059 478375 481105 481998 482573 485782 486195 486195 474692 475492 477059 478375 480643 481104 481105 481998 481999 482001 482572 482573 483028 483536 484044 485782 486195 487568 487569 487570 488316 489338 489879 489880 490140 486195 487570 490140 472838 472965 472966 472968 472969 473221 473749 474692 475491 475492 477059 477926 477983 477984 477985 478374 479256 479870 480216 480217 480641 480642 480643

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.