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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80490

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

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Event summary

Timeline bucket
April 13, 2018
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

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Z-2662-2018
Recall number
Z-2662-2018
Initiated
April 13, 2018
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
276 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Code information

Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421

Distribution pattern

US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.