Tri State Incorporated . Class II

Company: Tri State Incorporated
Date of Enforcement Report:2/12006
Class:lI

PRODUCT
Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders, Recall # D-144-6

REASON
cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and vacuum purge step during the prefill cycle..

CODE
All lots

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Tri State Incorporated, Wauseon, OH, by visit on December 9, 2005. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
359 cylinders

DISTRIBUTION
Nationwide