Drug Enforcement D-818-2013

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

Status

Terminated

Classification

Class II

Report Date

July 31, 2013

Termination Date

November 4, 2014

Product Information

Product description
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
Product quantity
94 cylinders
Reason for recall
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Recall initiation reason
Initial firm notification
Visit
Distribution pattern
Oklahoma

Location & Firm

Recalling firm
Oklahoma Respiratory Care Inc
Address
623 N Porter Ave Ste 100, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-818-2013
Event ID
65621
Recall initiation date
December 5, 2012
Center classification date
July 24, 2013
Code info
Lot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
More code info