The Recall Desk
HighFDA (Drugs)·D-0355-2021·Announced 2021-05-05

Grace Healthcare Recalls Compressed Oxygen Cylinders Due to Manufacturing Deviations

Grace Healthcare Medical, Inc. is voluntarily recalling 35,838 compressed oxygen cylinders nationwide due to cGMP deviations. The recall was initiated in April 2021.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which involves a risk of temporary or medically reversible adverse health consequences. Per the rubric, this aligns with a 'High' severity score, as it is a risk-of-harm product where specific injury reports are not detailed in the source text.

Plain-English summary

Grace Healthcare Medical, Inc. is voluntarily recalling 35,838 cylinders of Oxygen, Compressed, USP UN 1072. The affected product is packaged in cylinders labeled as M6, C, D, E, M, or H Medical Gas Cylinders and is available by prescription only. The recall covers all lots manufactured and distributed between April 1, 2019, and April 9, 2021.

The recall was initiated because of current Good Manufacturing Practice (cGMP) deviations. The FDA classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The product was distributed nationwide in the United States. The recall was initiated on April 15, 2021, and the status is currently terminated as of December 2, 2022. Consumers and healthcare providers should check their inventory for these specific cylinder types and contact the recalling firm for further instructions.

The recalled product

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 Gulfpo
Manufacturer
Grace Healthcare Medical, Inc
Category
Drug — Medical Gas
Hazard
Affected units
35,838

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · cGMP deviation

See all →