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

FDA recall notice · announced May 5, 2021 · Grace Healthcare Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

cGMP deviations

Notes

Distribution: USA Nationwide
Lot/code information: All lots manufactured and distributed 04/01/2019-04/09/2021
Quantity: 35,838 cylinders
Status: Terminated
Products in this recall event:
- 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 Cylinde (D-0355-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.