Air Gas
FDA Recall NDC 55037-302
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Air (NDC 55037-302). A significant event, classified as Class III, was initiated on Mar 10, 2015 by Matheson Tri-gas, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specification; out of specification results for carbon dioxide"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2015 Class III Recall: Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Recall Number
Class III Terminated
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Mar 10, 2015
Apr 01, 2015
137,880 cubic feet
Recall Profile & Regulatory Data
Event ID
70713
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Matheson, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Michigan and Wisconsin
Termination Date
Apr 17, 2015
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
55037-302-01Product
55037-302-02Product
55037-302-03Product
55037-302-04Product
55037-302-05Product
55037-302-06Product
55037-302-07Product
55037-302-08Product
55037-302-09Product
55037-302-10Product
55037-302-11Product
55037-302-12Product
55037-302-13Product
55037-302-14Product
55037-302-15Product
55037-302-16Product
55037-302-17Product
55037-302-18Product
55037-302-19Product
55037-302-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
