Exact FDA event identifier

Event 88675

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

Open FDA event record

Event summary

Timeline bucket: July 15, 2021
Product types: Device
Classifications: Class III
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

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Z-0163-2022

Recall number: Z-0163-2022
Initiated: July 15, 2021
Classification: Class III
Status: Terminated
Recalling firm: Smiths Medical ASD Inc.
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Two devices were labeled with the same serial number

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two devices were labeled with the same serial number

Code information

SN RF70121

Distribution pattern

UK