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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84985

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

Open FDA event record

Event summary

Timeline bucket
September 16, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
CME America, LLC

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

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.

Z-1442-2020
Recall number
Z-1442-2020
Initiated
September 16, 2019
Classification
Class I
Status
Terminated
Recalling firm
CME America, LLC
Quantity
69400 infusion sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

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

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

Code information

Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802

Distribution pattern

US: CA, OH, PA, and TX OUS: Canada