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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75557

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

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Event summary

Timeline bucket
October 31, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD, Inc.

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

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

Z-1145-2017
Recall number
Z-1145-2017
Initiated
October 31, 2016
Classification
Class III
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
33

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

Code information

S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.

Distribution pattern

Internationally to Finland