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Food and Drug Administration Adverse Determination Letter (ADL)


    ADL                                      Recalls and Significant Blood Safety Violations

              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a
  10/30/09
              malarial risk area).
              Recalled 1 Platelets Pheresis Leukocytes Reduced Irradiated Product due to collection (sterility may have been com-
  10/30/09
              promised).
              Recalled 93 Red Blood Cells Leukocytes Reduced Products due to collection (sterility may have been compromised and
  10/30/09
              failure to follow manufacturer's instructions).
              Recalled 72 Fresh Frozen Plasma Products due to collection (sterility may have been compromised and failure to follow
  10/30/09
              manufacturer's instructions).
              Recalled 53 Platelets Leukocytes Reduced Products due to collection (sterility may have been compromised and failure
  10/30/09
              to follow manufacturer's instructions).
              Recalled 1 Red Blood Cells Leukocytes Reduced Irradiated Product due to collection (sterility may have been compro-
  10/30/09
              mised and failure to follow manufacturer's instructions).
              Recalled 62 Red Blood Cells Leukocytes Reduced Products due to collection (sterility may have been compromised and
  10/30/09
              failure to follow manufacturer's instructions).
              Recalled 40 Fresh Frozen Plasma Products due to collection (sterility may have been compromised and failure to follow
  10/30/09
              manufacturer's instructions).
              Recalled 31 Platelets Leukocytes Reduced Products due to collection (sterility may have been compromised and failure
  10/30/09
              to follow manufacturer's instructions).
              Recalled 5 Red Blood Cells Leukocytes Reduced Irradiated Products due to collection (sterility may have been compro-
  10/30/09
              mised and failure to follow manufacturer's instructions).
              Recalled 1 Platelets Pheresis leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a
  10/30/09
              malarial risk area).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a
  10/30/09
              malarial risk area).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Plasma Frozen Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record
  10/30/09
              gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to component preparation (platelet yield too high for
  10/30/09
              storage in a single bag).
Southwest cont
Food and Drug Administration Adverse Determination Letter (ADL)


    ADL                                      Recalls and Significant Blood Safety Violations

              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect
  10/30/09
              Blood Donation Record gender-specific questions were answered).
              Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a
  10/30/09
              malarial risk area).
              Recalled 42 Platelets Pheresis Leukocytes Reduced Products due to donor collection (products collecting using
  10/30/09
              apheresis kits that had exceeded the acceptable time period for use).

				
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