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Lack of assurance of sterility.
Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.
Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.