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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85912

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2020
Product types
Device
Classifications
Class I
Statuses
Ongoing
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

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Z-2734-2020
Recall number
Z-2734-2020
Initiated
June 26, 2020
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
35616 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

Code information

Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Distribution pattern

Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago

device · product 2 of 2

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Z-2735-2020
Recall number
Z-2735-2020
Initiated
June 26, 2020
Classification
Class I
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
17019 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

Code information

Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0

Distribution pattern

Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago