Exact FDA event identifier

Event 93690

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

Event summary

Timeline bucket: December 28, 2023
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Fresenius Medical Care Holdings, Inc.

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 in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.

D-0218-2024

Recall number: D-0218-2024
Initiated: December 28, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 69,590 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance

Code information

Part Number: 077-60621, Lot #: 23JK02010, Exp. Date 1/31/2025

Distribution pattern

Nationwide within the United States