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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88446

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 26, 2021
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

1 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 1

Atrium Pneumostat Chest Drain Valve, Part Number 16100

Z-2592-2021
Recall number
Z-2592-2021
Initiated
August 26, 2021
Classification
Class II
Status
Ongoing
Quantity
92,430 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

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 firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

Code information

Lots 433297 433298 433974 433692 433693 434040 434962 435699 432585 435659 435660 436107 436106 437111 437530 438520 439396 439891 439905 440201 441182 441183 441392 441184 441185 441553 441554 443330 443362 443849 443968 445021 446022 447065 448203 447066 448138 448139 448618 448995 448996 450275 449702 449703 449992 449993 450659 450467 450923 450924 451439 452012 452013 453085 453472 452575 453404 454260 454344 454345 454803 454589 454850 455370 454851 455360 455359 455898 455900 455901 456447 456448 456904 456905 458298 458300 458299 458301 458642 458643 458644 458645 459216 461545 463439 463441 463469 463442 463443 463586 463587 464069 464103 464809 464104 464105 464669 465368

Distribution pattern

Domestic distribution nationwide. Foreign distribution worldwide.