Reported Dec 28, 2016 · Terminated

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

Sage Products LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sage Products LLC · 3909 3 Oaks Rd · Cary, IL · 60013-1804

3 of 3 products

Products covered by this recall
#	Product as published
1	3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50
2	8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80
3	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.

Lot codes and dates: 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
Amount recalled: 576,802 cases total for product codes 7503, 7905, and 7526

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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