FDA Drug recall D-0355-2021
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder
- FDA Drug
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder by Grace Healthcare Medical, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0355-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-15 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Grace Healthcare Medical |
| Distribution | US |
Product
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
Reason
cGMP deviations
Identifiers
| code_info | All lots manufactured and distributed 04/01/2019-04/09/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2021%22
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