D-386-2014 Class II Terminated
FDA drug recall D-386-2014 was initiated by Airgas Medical Services on October 10, 2013 and is designated Class II. 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. The recall status is terminated (terminated September 3, 2014). Affected quantity: 145 cylinders.
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2014
- Initiation Date
- October 10, 2013
- Termination Date
- September 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145 cylinders
Product Description
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
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.
Distribution Pattern
To medical facilities in New Hampshire, Vermont, Massachusetts, and New York.
Code Information
Lot # HS05A266E , size "E" and "D", NDC # 11054-009-XX Number and Part Numbers = USPE, USPEAC, USPDAC