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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93376

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

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Event summary

Timeline bucket
November 15, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare 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

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Z-0550-2024
Recall number
Z-0550-2024
Initiated
November 15, 2023
Classification
Class II
Status
Ongoing
Quantity
339,936 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Code information

UDI/DI 0085412153186, Lot Numbers: H23F23028, H23G11054, H23F24018, H23G12029, H23F24034, H23G13100, H23F24067, H23G14074, H23F25049, H23G15048, H23F25056, H23G16038, H23F26047, H23G17051, H23F26054, H23G18067, H23F27037, H23G19115, H23F27045, H23G20055, H23F27102, H23G22069, H23F28035, H23G23067, H23F28043, H23G24107, H23F29066, H23G25047, H23F30064, H23G25096, H23G01030, H23G26094, H23G02046, H23G27100, H23G05015, H23G28082, H23G06047, H23G30054, H23G07052, H23G31110, H23G08050, H23H04032, H23G09058, H23H05039, H23G10072

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.