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Home » FDA SEIZES PRODUCTS FROM CANADIAN FIRM FOR MDR FAILURES
FDA SEIZES PRODUCTS FROM CANADIAN FIRM FOR MDR FAILURES
April 16, 2004
The FDA has issued a detention order for all transcutaneous electrical nerve stimulator (TENS) devices and acupuncture needles shipped by a Canadian repackaging firm cited for failure to maintain adequate quality systems (QS) and medical device reporting (MDR) procedures.