Comfort Shield Barrier Cloth
FDA Recall NDC 53462-915
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Comfort Shield Barrier (NDC 53462-915). A significant event, classified as Class I, was initiated on Jul 29, 2016 by Sage Products Llc. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Jul 29, 2016
Dec 28, 2016
576,802 cases total for product codes 7503, 7905, and 7526
Recall Profile & Regulatory Data
Event ID
74819
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Sage Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Termination Date
Mar 11, 2019
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
53462-915-50Product
53462-915-51Product
53462-915-62Product
53462-915-80Product
53462-915-81Product
53462-915-24Product
53462-0915-62Product
Class II Terminated
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Jul 29, 2016
Dec 28, 2016
616,561 cases total
Recall Profile & Regulatory Data
Event ID
74819
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sage Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Termination Date
Mar 11, 2019
Product Description
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) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 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.
Batch or Lot Expiration Information
Lot# : a) 45489, Exp. 8/23/2016; 45537, Exp. 8/25/2016; 45631, Exp. 9/1/2016; 45781, Exp. 9/10/2016; 46345, Exp. 10/18/2016; 46708, Exp. 11/9/2016; 46763, Exp. 11/11/2016; 47378, Exp. 1/5/2017; 47723, Exp. 1/27/2017; 48347, Exp. 3/4/2017; 49057, Exp. 4/18/2017; 49498, Exp. 5/16/2017; 49576, Exp. 5/19/2017; 49869, Exp. 6/8/2017; 51306, Exp. 9/10/2017; 51309, Exp. 9/10/2017; 51720, Exp. 10/6/2017; 52187, Exp. 11/7/2017; 52216, Exp. 11/8/2017; 52226, Exp. 11/8/2017; 52235, Exp. 11/9/2017; 52239, Exp. 11/9/2017; 52415, Exp. 11/19/2017; 52694, Exp. 12/8/2017; 52702, Exp. 12/8/2017; 52711, Exp. 12/9/2017; 52722, Exp. 12/9/2017; 52968, Exp. 1/4/2018; 53000, Exp. 1/5/2018; 54543, Exp. 4/10/2018; 54597, Exp. 4/12/2018; 55814, Exp. 6/20/18; b) 45408, Exp. 8/17/2016; 45427, Exp. 8/18/2016; 45451, Exp. 8/19/2016; 45468, Exp. 8/20/2016; 45483, Exp. 8/21/2016; 45557, Exp. 8/26/2016; 45650, Exp. 9/2/2016; 45768, Exp. 9/9/2016; 45893, Exp. 9/17/2016; 45998, Exp. 9/23/2016; 46169, Exp. 10/5/2016; 46432, Exp. 10/22/2016; 46512, Exp. 10/27/16; 46551, Exp. 10/29/16; 46608, Exp. 11/2/16; 46647, Exp. 11/4/2016; 46669, Exp. 11/6/2016; 46841, Exp. 11/17/2016; 46851, Exp. 11/17/2016; 46970, Exp. 11/29/2016; 47058, Exp. 12/2/2016; 47115, Exp. 12/7/2016; 47202, Exp. 12/14/2016; 47309, Exp. 12/20/2016; 47420, Exp. 1/8/2017; 47436, Exp. 1/10/2017; 47512, Exp. 1/13/2017; 47560, Exp. 1/17/2017; 47800, Exp. 2/2/2017; 47837, Exp. 2/3/2017; 48134, Exp. 2/19/2017; 48154, Exp. 2/21/2017; 48928, Exp. 4/9/2017; 48943, Exp. 4/11/2017; 49149, Exp. 4/25/2017; 49222, Exp. 4/29/2017; 49386, Exp. 5/9/2017; 49466, Exp. 5/12/2017; 49600, Exp. 5/20/2017; 49926, Exp. 6/13/2017; 50578, Exp. 7/27/2017; 50585, Exp. 7/27/2017; 50596, Exp. 7/28/2017; 50600, Exp. 7/28/2017; 50910, Exp. 8/15/2017; 51204, Exp. 9/6/2017; 51260, Exp. 9/8/2017; 51268, Exp. 9/8/2017; 51293, Exp. 9/9/2017; 51344, Exp. 9/13/2017; 51438, Exp. 9/19/2017; 51522, Exp. 9/23/2017; 51527, Exp. 9/23/2017; 51531, Exp. 9/23/2017; 51755, Exp. 10/7/2017; 51824, Exp. 10/13/2017; 52016, Exp. 10/26/2017; 52079, Exp. 10/29/2017; 52083, Exp. 10/31/2017; 52263, Exp. 11/10/2017; 52308, Exp. 11/14/2017; 52397, Exp. 11/18/2017; 52407, Exp. 11/18/2017; 52538, Exp. 11/29/2017; 52614, Exp. 12/5/2017; 52615, Exp. 12/5/2017; 52644, Exp. 12/6/2017; 52659, Exp. 12/6/2017; 52661, Exp. 12/7/2017; 52676, Exp. 12/7/2017; 52737, Exp. 12/12/2017; 52946, Exp. 1/3/2018; 53359, Exp. 1/25/2018; 53624, Exp. 2/14/2018; 53724, Exp. 2/20/2018; 53849, Exp. 2/27/2018; 53850, Exp. 2/27/2018; 54498, Exp. 4/6/2018; 54544, Exp. 4/10/2018; 54653, Exp. 4/17/2018; 54693, Exp. 4/18/2018; 54734, Exp. 4/20/2018; 54771, Exp. 4/24/2018; 54856, Exp. 4/28/2018; 54945, Exp. 5/4/2018; 55365, Exp. 5/30/2018; 55629, Exp. 6/12/2018; 56255, Exp. 7/18/2018; 56263, Exp. 7/19/2018; 56273, Exp. 7/19/2018; 56353, Exp. 7/24/2018; 56410, Exp. 7/27/18; 56413, Exp. 7/27/18; 56532, Exp. 8/3/18; c) 46225, Exp. 10/8/2016; 46554, Exp. 10/29/2016; 46915, Exp. 11/22/2016; 49296, Exp. 5/3/2017; 49343, Exp. 5/5/2017; 50105, Exp. 6/23/17; 50626, Exp. 7/30/2017; 50634, Exp. 7/30/2017; 50639, Exp. 7/30/2017; 51310, Exp. 9/12/2017; 51313, Exp. 9/12/2017; 51340, Exp. 9/13/2017; 52388, Exp. 11/17/2017; 52395, Exp. 11/18/2017; 52403, Exp. 11/18/2017; 52421, Exp. 11/19/2017; 52912, Exp. 12/21/2017; 52915, Exp. 12/22/2017; 52918, Exp. 12/22/2017; 53508, Exp. 2/6/2018; 54815, Exp. 4/26/2018; 56307, Exp. 7/20/2018; 56311, Exp. 7/21/2018; 56316, Exp. 7/21/2018; 56457, Exp. 7/29/2018; 56561, Exp. 8/4/18; d) 53304, Exp. 1/23/2018; 53339, Exp. 1/24/2018; 53342, Exp. 1/24/2018; 53357, Exp. 1/25/2018; 55784, Exp. 6/19/2018; e) 50806, Exp. 2/7/2017; 52305, Exp. 5/15/2017; f) 48066, Exp. 8/18/2016; 48110, Exp. 8/20/2016; 48596, Exp. 9/20/2016; 48668, Exp. 9/23/2016; 49249, Exp. 11/1/2016; 49335, Exp. 11/4/2016; 49535, Exp. 11/16/2016; 50614, Exp. 1/28/2017; 50702, Exp. 2/2/2017; 50988, Exp. 2/21/2017; 51288, Exp. 3/11/2017; 51715, Exp. 4/6/2017; 51745, Exp. 4/8/2017; 51749, Exp. 4/8/2017; 51754, Exp. 4/8/2017; 51765, Exp. 4/9/2017; 51870, Exp. 4/18/2017; 52484, Exp. 5/26/2017; 52864, Exp. 6/20/2017; 53398, Exp. 8/1/2017; 54081, Exp. 9/12/2017; 54373, Exp. 9/29/2017; 55537, Exp. 12/7/2017; 56020, Exp. 1/4/2018; 56107, Exp. 1/9/2018
Affected Packages Involved in this Recall
53462-915-50Product
53462-915-51Product
53462-915-62Product
53462-915-80Product
53462-915-81Product
53462-915-24Product
53462-915-60Product
53462-0915-62Product
August 2014 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Aug 27, 2014
Sep 10, 2014
8-ct. 7,066 cases; 24-ct. 2,664 cases
Recall Profile & Regulatory Data
Event ID
69141
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sage Products Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 08, 2016
Product Description
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013
Batch or Lot Expiration Information
Lot# Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15
Affected Packages Involved in this Recall
53462-915-50Product
53462-915-51Product
53462-915-62Product
53462-915-80Product
53462-915-81Product
53462-915-24Product
53462-915-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
