Day

October 4, 2000
Class: IIPRODUCT Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A- 401. Recall #B-860-0. REASON The Autopheresis-C Plasmapheresis instruments with version 6.0 software may proceed to “Saline Rinse” without displaying the Remove Plasma prompt. CODE Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585 MANUFACTURER Baxter Healthcare Corporation, Largo, Florida. SOFTWARE DEVELOPER Baxter Healthcare Corporation, Round Lake,...
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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

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