FDA SPEEDS UP DEVICE RECALL POSTINGS

FDA SPEEDS UP DEVICE RECALL POSTINGS

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January 26th, 2017 – By Walter Eisner

The public is going to get information on recalled medical devices a little quicker in 2017. The FDA announced on January 3, 2017 that the agency is posting device recall information on its website earlier than in previous years.

The FDA used to post device recall information only after the agency announced the company’s initiation of a correction or removal action. Now, the agency is posting the information on the Center for Devices and Radiological Health’s (CDRH) Medical Device Recalls Database at the time the company takes a correction or removal action and notifies FDA that it can post the information, rather than at the time of FDA’s recall classification.

Click here to go to the agency’s recall page.

So far, there has only been one recall in 2017. Nurse Assist Inc. recalled the normal saline flush syringes due to incidents of Burkholderia cepacia (B. cepacia) contamination. B. cepacia is a bacterium that can cause bloodstream infections, particularly in patients with weak immune systems.

The FDA issued 39 device recalls in 2016, which was more than the 32 recalls from 2015 but significantly less than the 60 recalls from 2014.

 

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