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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80093

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

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Event summary

Timeline bucket
November 06, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.

Z-2111-2018
Recall number
Z-2111-2018
Initiated
November 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
25,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of incorrect priming volume due to manufacturing with incorrect tubing.

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

Reports of incorrect priming volume due to manufacturing with incorrect tubing.

Code information

Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167

Distribution pattern

US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA