Sage Products LLC recalls COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, fur
Recalled December 28, 2016 · FDA recall D-0229-2017 · Sage Products
Hazard
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. · FDA Class I
Units
576,802 cases total for product codes 7503, 7905, and 7526
Sold at
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Description
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Product
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
Manufacturer(s)
Sage Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →