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Recall Observatory FDA recall evidence

Drug product

Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009

D-386-2014

October 10, 2013

Class II

Product summary

Firm
Airgas Medical Services
Event
Event 66695
Status
Terminated
Classification
Class II
Quantity
145 cylinders
Official record key
drug-enforcement:D-386-2014

Official wording

Reason: Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.

Code information: Lot # HS05A266E , size "E" and "D", NDC # 11054-009-XX Number and Part Numbers = USPE, USPEAC, USPDAC

Distribution pattern: To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    error in the manufacturing