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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88198

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

Open FDA event record

Event summary

Timeline bucket
June 25, 2021
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

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Z-2137-2021
Recall number
Z-2137-2021
Initiated
June 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
36,144 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

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

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

Code information

Lot Number: 0061761278

Distribution pattern

Affected products were distributed to the following US states: CA, MI, OR, and UT.