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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90809

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

Open FDA event record

Event summary

Timeline bucket
September 02, 2022
Product types
Device
Classifications
Class III
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

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

Z-1817-2022
Recall number
Z-1817-2022
Initiated
September 02, 2022
Classification
Class III
Status
Ongoing
Quantity
9,671 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling has incorrect or incomplete

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

Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

Code information

All serial numbers after 6/2016. Product code CMMST5 - Incorrect UDI-DI: 7290013030269; correct UDI-DI: 07290013030269. Product code CMM-ST5 - Incorrect UDI-DI: 7290013030030; correct UDI-DI: 07290013030030. Product code CMABATT - Incorrect UDI-DI: 7290013030160; correct UDI-DI: 07290013030160. Product code CMASC10 - Incorrect UDI-DI: 7290013030054; correct UDI-DI: 07290013030054.

Distribution pattern

US Nationwide Distribution and government/military distribution.