The Recall Desk
ModerateFDA (Drugs)·D-0782-2016·Announced 2016-04-06

Praxair Recalls 127 Cylinders of Compressed Medical Air Due to Odor

Praxair Inc. is recalling 127 cylinders of compressed medical air because a customer reported an odor when turning on a cylinder.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The agency classified this as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a reported odor indicating a CGMP deviation, but no illnesses or injuries are reported, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Praxair Inc. is recalling 127 cylinders of UN1002 Air, Compressed, Breathing Grade, USP. The product is distributed by Praxair Distribution, Inc. in Roseville, MN, and carries NDC 59579-006.

The recall was initiated due to confirmed Current Good Manufacturing Practice (CGMP) deviations. Specifically, a customer reported an odor when turning on a cylinder of medical air. The affected units are distributed nationwide and include specific lot numbers listed in the recall documentation.

Consumers and healthcare facilities should check their inventory for the affected lot numbers and stop using the product if it matches the recall description. Praxair Inc. is the recalling firm responsible for this action.

The recalled product

Product
UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
Manufacturer
Praxair Inc.
Category
Drug — Medical Gas
Hazard
Affected units
127

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 (20)

  • Lot # P411517501
  • P411517601
  • P411517701
  • P411518001
  • P411518101
  • P411518201
  • P411518202
  • P411518301
  • P411518701
  • P411518801
  • P411518901
  • P411519101
  • P411519401
  • P411519601
  • P411519602
  • P411519701
  • P411520101
  • P411520301
  • P411520401
  • P411520901

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Praxair Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Praxair Inc.

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Same hazard · odor

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