October 2013 FDA Recall Drug by Airgas Medical Services
D-386-2014 - Short Fill

This Class II drug recall was voluntarily initiated by Airgas Medical Services on October 10, 2013 for the product Drug. The FDA reported the reason for recall as short fill. The product was distributed in To medical facilities in New Hampshire, Vermont, Massachusetts, and New York. and the recall is currently terminated.

Recall Number: D-386-2014

Reason for Recall
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Initiated
10-10-2013
Reported
01-01-2014
Quantity
145 cylinders

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66695
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-03-2014
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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