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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82305

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roberts Home Medical 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

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

Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875

D-1002-2019
Recall number
D-1002-2019
Initiated
December 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Roberts Home Medical LLC
Quantity
9 Reservoirs

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, 01002100318. No expiration date, but an evaporation rate of approximately 60 days from fill date depending on head pressure of reservoir.

Distribution pattern

Product was distributed in MD, VA and the District of Columbia