Exact FDA event identifier

Event 79501

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

Event summary

Timeline bucket: November 13, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Fresenius Medical Care Renal Therapies Group, LLC

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

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

D-0827-2018

Recall number: D-0827-2018
Initiated: November 13, 2017
Classification: Class II
Status: Terminated
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Quantity: 25,356 1 liter 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

Code information

Lot # 17LU05005; Exp. 09/18 Part Number 060-10109

Distribution pattern

Product was distributed throughout the United States.