Exact FDA event identifier

Event 87809

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

Event summary

Timeline bucket: April 14, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Fresenius Medical Care, North America

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

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451

D-0389-2021

Recall number: D-0389-2021
Initiated: April 14, 2021
Classification: Class II
Status: Terminated
Recalling firm: Fresenius Medical Care, North America
Quantity: 709 cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling; Label Mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

Code information

Lot #20SU03019, Exp 6/2022

Distribution pattern

USA Nationwide