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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67714

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 17, 2014
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

2 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 2

Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

Z-1443-2014
Recall number
Z-1443-2014
Initiated
March 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
393,210

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

Code information

2509489 2509490 2509491 2509491 2509493 2513256 2513257 2513258 2513259 2513259 2523835 2528502 2528503 2528505 2531609 2531609 2536970 2536971 2536972 2540530 2540531 2540531 2540533 2540534 2540535 2540536 2540537 2540537 2549516 2553479 2553480 2553481 2558317 2558317 2558324 2563120 2563123 2567637 2567638 2567638 2567640 2572571 2573607 2576408 2577526 2577526 2585112 2585113 2586060 2588651 2588652 2588652 2590076 2597393 2597394 2600985 2602457 2602457 2602460 2607387 2607389 2607390 2610674 2610674 2614827 2615844 2615845 2615846 2620953 2620953 2620957 2621091 2621096

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.

device · product 2 of 2

Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

Z-1444-2014
Recall number
Z-1444-2014
Initiated
March 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
870 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

Code information

2513261 2531612 2540540 2545044 2588656

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.