The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1002-2019·Announced 2019-03-20

Roberts Home Medical Recalls Refrigerated Liquid Oxygen Cylinders Due to CGMP Deviations

Roberts Home Medical LLC is voluntarily recalling 9 refrigerated liquid oxygen reservoirs due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Maryland, Virginia, and the District of Columbia.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves CGMP deviations in a life-support medication (oxygen), which fits the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the source text.

Plain-English summary

Roberts Home Medical LLC has voluntarily initiated a recall of 9 refrigerated liquid oxygen reservoirs. The recall was initiated on December 19, 2018, and was classified as Class II by the U.S. Food and Drug Administration. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations.

The affected product is Oxygen, Refrigerated Liquid USP, which is prescription-only and supplied in cylinders. The specific lots involved are 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518, and 01002100318. The product does not have an expiration date but has an evaporation rate of approximately 60 days from the fill date, depending on the head pressure of the reservoir.

The product was distributed in Maryland, Virginia, and the District of Columbia. The recall status is currently terminated, with a termination date of May 1, 2019. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
Manufacturer
Roberts Home Medical LLC
Category
Drug — Oxygen Therapy
Hazard
Affected units
9

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 (9)

  • Lot # 01005100518
  • 01010101918
  • 01011101918
  • 01007112118
  • 01001100318
  • 01007072518
  • 01017120518
  • 01011090518
  • 01002100318. No expiration date

Distribution

Distributed in 3 states:

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