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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71735

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MRP, LLC dba AMUSA

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

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

Z-2476-2015
Recall number
Z-2476-2015
Initiated
July 02, 2015
Classification
Class II
Status
Terminated
Recalling firm
MRP, LLC dba AMUSA
Quantity
551 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Procedures for the acceptance and control of in-process product have not been adequately established.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Procedures for the acceptance and control of in-process product have not been adequately established.

Code information

KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016

Distribution pattern

Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.