FDA recall D-1383-2012

Linde Gas LLC · Class II · drug

Product

LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde

Reason for recall

CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.

Distribution

Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.

Key facts

Status: Terminated
Initiation date: 2012-05-04
Report date: 2012-06-27
Termination date: 2013-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1383-2012