FDA recall D-0776-2016

Product

Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.

Reason for recall

CGMP Deviations: Cylinders filled using out of date gauges.

Distribution

U.S. Including: Oklahoma

Key facts

Status

Terminated

Initiation date

2016-02-05

Report date

2016-03-23

Termination date

2016-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bartlesville, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2016