DRAINAGE BAGS WERE DISTRIBUTED UPON RECEIPT OF SUPPLIER'S CERTIFICATE OF STERILITY TO VARIOUS CUSTOMERS. PRODUCT SAMPLES WERE SENT TO 3RD PARTY STERILITY VERIFICATION. ON JULY 20, 2007, TESTING LABORATORY NOTIFIED COMPANY OF POSITIVE TEST RESULTS. AS A RESULT OF CONTACTING THE FACILITIES, WHERE PRODUCT WAS DISTRIBUTED, COMPANY WAS NOTIFIED OF 2 PATIENTS AT DIFFERENT FACILITIES THAT HAVE DEVELOPED URINARY TRACT INFECTIONS. IN BOTH CASES, THE FACILITY STATED THAT THERE WAS NO WAY TO DETERMINE IF THE INFECTION WAS A RESULT OF THE DRAINAGE BAGS.
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Patient 1
ON JUNE 28, 2007, PRODUCTS WERE RECEIVED IN FROM OUR SUPPLIER WITH CERTIFICATE OF STERILITY AS REQUIRED BY INCOMING INSPECTION SPECIFICATIONS. BECAUSE THIS WAS ONLY THE 2ND ORDER TO BE RECEIVED FROM THE SUPPLIER, REMINGTON MEDICAL REQUIRED VERIFICATION OF THE STERILITY THUS, SAMPLES WERE SENT TO OUTSIDE TESTING LABORATORY. ON JULY 20, 2007, THE TESTING FACILITY REPORTED, THE PRODUCT SAMPLES HAD BACTERIAL GROWTH. A FIRM INITIATED RECALL WAS INITIATED AS A RESULT OF THE TEST RESULTS.