Exact FDA event identifier

Event 82966

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

Open FDA event record

Event summary

Timeline bucket: May 01, 2019
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: B. Braun Medical, 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

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032

Z-2489-2019

Recall number: Z-2489-2019
Initiated: May 01, 2019
Classification: Class I
Status: Terminated
Recalling firm: B. Braun Medical, Inc.
Quantity: 2580

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

Code information

Lot Number 0061641410

Distribution pattern

Distribution to US state of TX, and Canada.