U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Micromedics, inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
조치
Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement.
Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.
Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
제품 설명
AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS700-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA