Exact FDA event identifier

Event 85405

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

Open FDA event record

Event summary

Timeline bucket: April 07, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corporation

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

Prismaflex Control Unit

Z-2066-2020

Recall number: Z-2066-2020
Initiated: April 07, 2020
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corporation
Quantity: 5 devices US territories

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

Code information

Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.

Distribution pattern

Distribution only to Puerto Rico and Guam