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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80231

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

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Event summary

Timeline bucket
June 04, 2018
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

26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550

Z-2343-2018
Recall number
Z-2343-2018
Initiated
June 04, 2018
Classification
Class II
Status
Terminated
Recalling firm
B. Braun Medical, Inc.
Quantity
12320

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

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

There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

Code information

0061546906, 0061546910, 0061548145, 0061548146, 0061548476, 0061548477, 0061548478, 0061548479, 0061548645, 0061555100, 0061555101, 0061555102, 0061556350, 0061557521, 0061559077, 0061559628, 0061559631, 0061559852, 0061559853, 0061559854, 0061560830, 0061560831, 0061562493, 0061562494, 0061562941, 0061563541, 0061564175, 0061564176, 0061564177, 0061564179, 0061564180, 0061564431, 0061564669, 0061564670, 0061564672, 0061564673, 0061566362, 0061566363, 0061567272, 0061567809, 0061567810, 0061567811, 0061567812, 0061567813, 0061567814, 0061571324, 0061571325, 0061571326, 0061571327, 0061572464, 0061572465, 0061572466, 0061572980, 0061572981, 0061572982, 0061572983, 0061572984, 0061572985, 0061572987, 0061579647, 0061579648, 0061579651, 0061579653, 0061579654, 0061581522, 0061581585, 0061581586, 0061581590, 0061581599, 0061581602, 0061581603, 0061581982, 0061581983, 0061581984, 0061581985, 0061581986, 0061581987, 0061581988, 0061583281, 0061583282, 0061583283, 0061586220, 0061586221, 0061586222, 0061586223, 0061586224, 0061586712, 0061586713, 0061586714, 0061587151, 0061587152, 0061587153, 0061587154, 0061587155, 0061587156, 0061587157, 0061587720, 0061590070, 0061591603, 0061591618, 0061591646, 0061591660, 0061591662, 0061591663, 0061591664, 0061591665, 0061591667, 0061591675, 0061594365, 0061594366, 0061594367, 0061594368, 0061594369, 0061599040, 0061599159, 0061599160, 0061599161, 0061599162, 0061599163, 0061599164, 0061599165, 0061603919, 0061603920, 0061603921, 0061608039, 0061614625, 0061614626, 00VL559752

Distribution pattern

The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.