COMFORT SHIELD Barrier Cream Cloths recalled over sterility concerns

Recall date

July 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sage Products LLC recalls COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, fu…

Recall number

D-0229-2017

FDA classification

Class I

Brand / firm

Sage Products LLC

Sold / distributed

Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.