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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.