FDA recall D-386-2014

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

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

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

Key facts

Status

Terminated

Initiation date

2013-10-10

Report date

2014-01-01

Termination date

2014-09-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Radnor, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-386-2014