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;

Recall Insight

This FDA Drug action (record #D-0229-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on July 29, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Sage Products LLC is listed as the recalling firm, operating out of Cary, IL. Federal records list the affected scope as 576,802 cases total for product codes 7503, 7905, and 7526.

The documented reason for this recall is: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. Distribution data in the federal record shows the product reached: Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.