November 2013 FDA Recall Drug by Airgas Medical Services
D-366-2014 - Labeling

This Class II drug recall was voluntarily initiated by Airgas Medical Services on November 6, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Kansas, Missouri, and Arkansas. and the recall is currently terminated.

Recall Number: D-366-2014

Reason for Recall
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.
Initiated
11-06-2013
Reported
12-25-2013
Quantity
264 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66929
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Airgas Medical Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Kansas, Missouri, and Arkansas.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2014
Product Description About Product Description
Full technical description of the product.
Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA

Batch or Lot Expiration Information

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