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

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  February 4-6, 2020
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Dates:  June 2-4, 2020
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