Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85997

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

Open FDA event record

Event summary

Timeline bucket
August 04, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CareFusion 303, 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

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.

Z-2935-2020
Recall number
Z-2935-2020
Initiated
August 04, 2020
Classification
Class II
Status
Ongoing
Recalling firm
CareFusion 303, Inc.
Quantity
680 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Infusion pump component defect may result in interruption of patient monitoring

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Infusion pump component defect may result in interruption of patient monitoring

Code information

Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569

Distribution pattern

U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None