Class I
Terminated
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.
- Company
- Sage Products Llc
- Recall Initiated
- July 29, 2016
- Posted
- December 28, 2016
- Recall Number
- D-0229-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 576,802 cases total for product codes 7503, 7905, and 7526
- Firm Location
- Cary, IL, United States
Reason for Recall
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Distribution
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Lot / Code Info
Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17
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