Status
Terminated
Drug Enforcement D-1383-2012
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.
Classification
Class II
Report Date
June 27, 2012
Termination Date
June 11, 2013
Product Information
- Product description
- LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
- Product quantity
- 283 cylinders
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Other
- Distribution pattern
- Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product.
Location & Firm
- Recalling firm
- Linde Gas LLC
- Address
-
7029 Huntley Rd Ste K, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1383-2012
- Event ID
- 61917
- Recall initiation date
- May 4, 2012
- Center classification date
- June 15, 2012
- Code info
- LOT#: 117H201 LOT#: 117H202
- More code info
- —