Recall – Blood products collected during software error distributed

Company: Mississippi Valley Reg Bld Ctr
Date of Enforcement Report: 8/7/2019
Class II

PRODUCT

Red Blood Cells, Leukocytes Reduced

  • Recall Number: B-0768-2019

Platelets

  • Recall Number: B-0769-2019

REASON

Blood products, collected during a software error with blood mixers, were distributed.

RECALLING FIRM/MANUFACTURER

Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 units

DISTRIBUTION

US Nationwide

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.