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Recall Observatory FDA recall evidence

Drug product

Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA

D-366-2014

November 06, 2013

Class II

Product summary

Firm
Airgas Medical Services
Event
Event 66929
Status
Terminated
Classification
Class II
Quantity
264 cylinders
Official record key
drug-enforcement:D-366-2014

Official wording

Reason: Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.

Code information: NDC 11054-002 Lot # TY00A260A Size G and H Part number 835148

Distribution pattern: Kansas, Missouri, and Arkansas.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    error in the manufacturing