FDA recall record

AIR COMPRESSED, Medical Air, USP recall — FDA D-0423-2015

Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Class IIIclassification
D-0423-2015official record ID
Apr 1, 2015report date

Recall record at a glance

Official recordD-0423-2015
CategoryDrug Recalls
ClassificationClass III
FDA record statusTerminated
Recalling firmMatheson, Inc.
Report dateApr 1, 2015
Recall initiation dateMar 10, 2015
Quantity137,880 cubic feet
LocationNew Brighton, MN, United States

Official product description

AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.

Why the product was recalled

Failed Impurities/Degradation Specification; out of specification results for carbon dioxide

Distribution information

Michigan and Wisconsin

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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