Exact FDA event identifier

Event 68728

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 11, 2014
Product types: Drug
Classifications: Class I
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

3 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 3

0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

D-1591-2014

Recall number: D-1591-2014
Initiated: July 11, 2014
Classification: Class I
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: a) 217,536 bags; b) 161,760 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Code information

Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14

Distribution pattern

Nationwide, Puerto Rico, Singapore, and Hong Kong

drug · product 2 of 3

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.

D-1592-2014

Recall number: D-1592-2014
Initiated: July 11, 2014
Classification: Class I
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 390,560 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

Code information

Lot #: P308650, Exp 10/14

Distribution pattern

Nationwide, Puerto Rico, Singapore, and Hong Kong

drug · product 3 of 3

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.

D-1593-2014

Recall number: D-1593-2014
Initiated: July 11, 2014
Classification: Class I
Status: Terminated
Recalling firm: Baxter Healthcare Corp.
Quantity: 171,672 bags

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Code information

Lot #: P309476, Exp 10/14

Distribution pattern

Nationwide, Puerto Rico, Singapore, and Hong Kong