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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87742

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Grace Healthcare Medical, 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

Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331

D-0355-2021
Recall number
D-0355-2021
Initiated
April 15, 2021
Classification
Class II
Status
Terminated
Quantity
35,838 cylinders

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

All lots manufactured and distributed 04/01/2019-04/09/2021

Distribution pattern

USA Nationwide