Exact FDA event identifier

Event 69868

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

Event summary

Timeline bucket: November 25, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Baxter Healthcare Corp.

Dossier provenance

Source snapshots represented here

openFDA Drug 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.

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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.

drug · product 1 of 1

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

D-0301-2015

Recall number: D-0301-2015
Initiated: November 25, 2014
Classification: Class II
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 7,220 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Code information

Product Code 2B7717 Lot # P311357, exp 12/31/2015

Distribution pattern

Nationwide