Exact FDA event identifier

Event 62389

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

Open FDA event record

Event summary

Timeline bucket: June 27, 2012
Product types: Device
Classifications: Class II
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

Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments

Z-1979-2012

Recall number: Z-1979-2012
Initiated: June 27, 2012
Classification: Class II
Status: Terminated
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 2247 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

Code information

All serial numbers

Distribution pattern

US Nationwide Distribution