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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 1 Red Blood Cells Product due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 43 Red Blood Cells Leukocytes Reduced Products due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Irradiated Product due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 5 Fresh Frozen Plasma Products due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 633 Red Blood Cells Leukocytes Reduced Products due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 19 Fresh Frozen Plasma Products due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 5 Red Blood Cells Leukocytes Reduced Irradiated Products due to inadequate arm prep; sterility may have been compromised.

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

10/30/09:
Recalled 37 Plasma Frozen Products due to inadequate arm prep; sterility may have been compromised.

10/30/09:
Recalled 2 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to failure to control suspect blood component(s) (release of blood component from a donor who was previously incarcerated).

10/30/09:
Recalled 1 Recovered Plasma Product due to failure to control suspect blood component(s) (release of blood component from a donor who was previously incarcerated).

2/6/08:
Recalled 2 Red Blood Cells Pheresis Leukocytes Reduced Products due to donor eligibility (donor involved in a possible recipient transfusion transmitted infection case was not deferred).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a CreutzfeldtJakob Disease (CJD) risk area).

2/6/08:
Recalled 1 Recovered Plasma Product due to donor eligibility (failure to defer donor for travel in a Creutzfeldt Jakob Disease (CJD) risk area).

2/6/08:
Recalled 7 Fresh Frozen Plasma Products due to failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells).

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

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: The review of [REDACTED TEXT] and no documetation that products were placed in controlled temperature storage, and the associated Corrective Action, Issue Detail [REDACTED TEXT] revealed that [REDACTED TEXT] [REDACTED TEXT] failed to perform the following notifications on [REDACTED TEXT] out of [REDACTED TEXT]n-date leukoreduced red blood cell components identified by the [REDACTED TEXT] as being subject to recall: a) Follow-up with written notification to the consignee within 10 [REDACTED TEXT]. The review of the [REDACTED TEXT] for [REDACTED TEXT] revealed that the second written notification for those consignees that failed to repond to the initial notifications [REDACTED TEXT] the 48 hour notification was performed for [REDACTED TEXT] performed [REDACTED TEXT] where the consignee failed to respond to the initial written notification.

Download the pdf file to read the complete inspection report.