Johnson & Johnson—Various Bandage Products: May Contain Undeclared Rubber Latex

April 4, 2018 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

FDA's Center for Devices and Radiological Health (CDRH) states that the current labels on the above products state that the products are not made with natural rubber latex; however, natural latex was used as a base ingredient in the early-stage manufacturing process (which reduces the allergic protein found in natural latex). FDA's CDRH also states that the manufacturer initiated a recall by Urgent Medical Device Recall letter on December 18, 2017. The manufacturer has not confirmed the...

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