Recalls / Class III
Class IIID-0423-2015
Product
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.
- Brand name
- Air
- Generic name
- Air
- Active ingredient
- Air
- Route
- Respiratory (inhalation)
- NDC
- 55037-302
- FDA application
- NDA205890
- Affected lot / code info
- A) Lot #: BAHC564281A, BAHC564281B, BAHC546288A, BAHC564288B, BAHC546288C, BAHC546288D, BAHC546288E, BAHC564307A, BAHC564314A, BAHC564329A. BAHC564329B, BAHC564329C, BAHC564329D, BAHC564329E, BAHC564344A, BAHC565005A, BAHC565006A, BAHC565013A, BAHC565015A, BAHC565015B, BAHC565015C, BAHC565015D, BAHC565029A, BAHC565035A. BAHC565035B, BAHC565035D; B) Lot #: BAHC564282A, BAHC564296A, BAHC564303A, BAHC564344A, BAJC565016A, BAHC565034A, BAHC565043A, BAHC565054A; C) Lot #: BAHC564269A, BAHC564275A, BAHC564282A, BAHC564288A, BAHC564296A, BAHC564303A, BAHC564308A, BAHC564317A, BAHC564324A, BAHC564329A, BAHC564338A, BAHC564344A, BAHC564351A, BAHC565016A, BAHC565020A, BAHC565028A, BAHC565043A, BAHC565054A; D) Lot #: BAHC564365A; E) Lot #: BAHC564269A, BAHC564275A, BAHC564279A, BAHC564282A, BAHC564290A, BAHC564296A, BAHC564303A, BAHC564308A, BAHC564317, BAHC564324A, BAHC564329A, BAHC564350A, BAHC564356A, BAHC564365A, BAHC565005A, BAHC565006A, BAHC565013A, BAHC565020A, BAHC565029A, BAHC565042A, BAHC565054A.
Why it was recalled
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Recalling firm
- Firm
- Matheson, Inc.
- Manufacturer
- Matheson Tri-Gas, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 305 2nd St Nw Ste 125, New Brighton, Minnesota 55112-3279
Distribution
- Quantity
- 137,880 cubic feet
- Distribution pattern
- Michigan and Wisconsin
Timeline
- Recall initiated
- 2015-03-10
- FDA classified
- 2015-03-23
- Posted by FDA
- 2015-04-01
- Terminated
- 2015-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0423-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.