FDAClass IIAugust 15, 2012

Oxygen recall: CGMP Deviations

OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory…

Why was Oxygen recalled?

CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots distributed January 1, 2011 - October 18, 2011.

Product
OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory…
Recalling firm
Oklahoma Respiratory Care Inc
Quantity
861 cylinders
Distribution
OK
Recall date
August 15, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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