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Recalls and Significant Blood Safety Violations

10/30/09
Region failed to promptly develop correction action plan for moderate risk trend problem (plasma preparation tubes without gel separator).

10/30/09
Region failed to promptly develop correction action plan for moderate risk trend problem (apheresis collection device defects).

10/30/09
Region failed to promptly develop correction action plan for three moderate risk trend problems (unacceptable or undocumented donor temperatures).

10/30/09
Recalled 2 Platelets Pheresis Leukocytes Reduced Products due to donor eligibility (Blood Donation Record question related to CJD was unanswered).

10/30/09
Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to failure to control suspect blood component(s) (product distributed prior to resolution of a quality control failure for platelet yield).

10/30/09
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09
Recalled 2 Red Blood Cells Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 35 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 17 Platelets Leukocytes Reduced due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 11 Fresh Frozen Plasma due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 1 Red Blood Cells Leukocytes Reduced Irradiated Product due to donor eligibility (Blood Donation Record questions unanswered).

10/30/09
Recalled 141 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 5 Red Blood Cells Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09
Recalled 2 Red Blood Cells Leukocytes Reduced Irradiated Products due to collection (inadequate arm prep; sterility may have been compromised).

The following excerpt is from page 2 of this 3-page FDA Inspection Report:

1. [REDACTED TEXT] was initiated on 1/9/09 because a male donor was registered as female at the collection site for units [REDACTED TEXT] and [REDACTED TEXT] [REDACTED TEXT] requires retrieval for units collected with an incomplete donor health history. [REDACTED TEXT] was initiated by DCSC to document the notification and retrieval of the components manufactured from the units. Initial written consignee notification was sent on 1/9/09 regarding both units. Final written notification for the leukoreduced platelet components of unit [REDACTED TEXT] was not sent until 5/28/09, The final disposition for the frozen plasma component of unit [REDACTED TEXT] is listed as transfused on the [REDACTED TEXT] however, the disposition form is missing from the case file and the final disposition could not be verified. The late notification and missing disposition form were not noted in the [REDACTED TEXT] review performed by a Process Verifier on 7/29/09. Problems [REDACTED TEXT] were not logged into the Automated Problem Management System (APMS) for the missed timeline and the missing document until 6/2/10.

Download the pdf file to read the complete inspection report.