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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67172

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

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Event summary

Timeline bucket
December 13, 2013
Product types
Device
Classifications
Class II
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 AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.

Z-0921-2014
Recall number
Z-0921-2014
Initiated
December 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
30, 240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

Code information

Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151, expiration 7/2018.

Distribution pattern

US Distribution one importer/wholesale distributor in MO.