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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94479

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

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Event summary

Timeline bucket
April 18, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
BD SWITZERLAND SARL

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 Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.

Z-1944-2024
Recall number
Z-1944-2024
Initiated
April 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
BD SWITZERLAND SARL
Quantity
11.300 sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

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

Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

Code information

Catalog Number: 10013072 UDI-DI code:07613203021210 Lot Number: 22115368

Distribution pattern

Worldwide - US Nationwide distribution in the states of AR, CA, CO, IL, KS, MA, ME, NJ, NY, PA, SD, WA and WI. The country of Canada.