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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94887

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

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Event summary

Timeline bucket
June 18, 2024
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

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 LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94

D-0608-2024
Recall number
D-0608-2024
Initiated
June 18, 2024
Classification
Class II
Status
Ongoing
Quantity
183 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Code information

24AU03024, exp. date 07/31/2025

Distribution pattern

Nationwide