FDA-Drug2016-12-28Class I

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;

Sage Products LLC
Hazard

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

Sold states
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Affected count
576,802 cases total for product codes 7503, 7905, and 7526
Manufactured in
3909 3 Oaks Rd, N/A, Cary, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2017

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