FDA recall D-818-2013

Oklahoma Respiratory Care Inc · Class II · drug

Product

Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071

Reason for recall

Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.

Distribution

Oklahoma

Key facts

Status: Terminated
Initiation date: 2012-12-05
Report date: 2013-07-31
Termination date: 2014-11-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norman, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-818-2013