Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde |
|---|---|
| Recall Number | D-1383-2012 |
| Classification | Class II |
| Code Info | LOT#: 117H201 LOT#: 117H202 |
| Product Distributed Qty | 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. |
Event Detail
| Event Id | 61917 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Linde Gas LLC |
| City | Columbus |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-04 |
| Initial Firm Notification of Consignee or Public | Other |
| Distribution Pattern | Distributed only within Ohio. No Federal Government, foreign or Canadian consignees received product. |
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