Sage Products Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination
CARY, Illinois, USA, Aug. 19, 2016 /PRNewswire/ -- Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail and consumer/user levels. The recall is being initiated due to potential product contamination with the bacteria, Burkholderia cepacia.
Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. The recalled products were distributed to distributors, healthcare facilities and retailers in the United States, Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates. The recalled products contain single-use, disposable cloths and were distributed between August 2014 and August 2016. The list of affected products and their corresponding lot numbers are indicated below.
Comfort Shield® Barrier Cream Cloths
| Lot # |
Product |
Description |
Expiry |
NDC |
| 45489 |
7503 |
COMFORT SHIELD 3-PACK |
8/23/16 |
53462-915-50 |
| 45537 |
7503 |
COMFORT SHIELD 3-PACK |
8/25/16 |
53462-915-50 |
| 45631 |
7503 |
COMFORT SHIELD 3-PACK |
9/1/16 |
53462-915-50 |
| 45781 |
7503 |
COMFORT SHIELD 3-PACK |
9/10/16 |
53462-915-50 |
| 46345 |
7503 |
COMFORT SHIELD 3-PACK |
10/18/16 |
53462-915-50 |
| 46708 |
7503 |
COMFORT SHIELD 3-PACK |
11/9/16 |
53462-915-50 |
| 46763 |
7503 |
COMFORT SHIELD 3-PACK |
11/11/16 |
53462-915-50 |
| 47378 |
7503 |
COMFORT SHIELD 3-PACK |
1/5/17 |
53462-915-50 |
| 47723 |
7503 |
COMFORT SHIELD 3-PACK |
1/27/17 |
53462-915-50 |
| 48347 |
7503 |
COMFORT SHIELD 3-PACK |
3/4/17 |
53462-915-50 |
| 49057 |
7503 |
COMFORT SHIELD 3-PACK |
4/18/17 |
53462-915-50 |
| 49498 |
7503 |
COMFORT SHIELD 3-PACK |
5/16/17 |
53462-915-50 |
| 49576 |
7503 |
COMFORT SHIELD 3-PACK |
5/19/17 |
53462-915-50 |
| 49869 |
7503 |
COMFORT SHIELD 3-PACK |
6/8/17 |
53462-915-50 |
| 51306 |
7503 |
COMFORT SHIELD 3-PACK |
9/10/17 |
53462-915-50 |
| 51309 |
7503 |
COMFORT SHIELD 3-PACK |
9/10/17 |
53462-915-50 |
| 51720 |
7503 |
COMFORT SHIELD 3-PACK |
10/6/17 |
53462-915-50 |
| 52187 |
7503 |
COMFORT SHIELD 3-PACK |
11/7/17 |
53462-915-50 |
| 52216 |
7503 |
COMFORT SHIELD 3-PACK |
11/8/17 |
53462-915-50 |
| 52226 |
7503 |
COMFORT SHIELD 3-PACK |
11/8/17 |
53462-915-50 |
| 52235 |
7503 |
COMFORT SHIELD 3-PACK |
11/9/17 |
53462-915-50 |
| 52239 |
7503 |
COMFORT SHIELD 3-PACK |
11/9/17 |
53462-915-50 |
| 52415 |
7503 |
COMFORT SHIELD 3-PACK |
11/19/17 |
53462-915-50 |
| 52694 |
7503 |
COMFORT SHIELD 3-PACK |
12/8/17 |
53462-915-50 |
| 52702 |
7503 |
COMFORT SHIELD 3-PACK |
12/8/17 |
53462-915-50 |
| 52711 |
7503 |
COMFORT SHIELD 3-PACK |
12/9/17 |
53462-915-50 |
| 52722 |
7503 |
COMFORT SHIELD 3-PACK |
12/9/17 |
53462-915-50 |
| 52968 |
7503 |
COMFORT SHIELD 3-PACK |
1/4/18 |
53462-915-50 |
| 53000 |
7503 |
COMFORT SHIELD 3-PACK |
1/5/18 |
53462-915-50 |
| 53957 |
7503 |
COMFORT SHIELD 3-PACK |
3/6/18 |
53462-915-50 |
| 54543 |
7503 |
COMFORT SHIELD 3-PACK |
4/10/18 |
53462-915-50 |
| 54597 |
7503 |
COMFORT SHIELD 3-PACK |
4/12/18 |
53462-915-50 |
| 55814 |
7503 |
COMFORT SHIELD 3-PACK |
6/20/18 |
53462-915-50 |
| 45408 |
7905 |
COMFORT SHIELD 8-PACK |
8/17/16 |
53462-915-80 |
| 45427 |
7905 |
COMFORT SHIELD 8-PACK |
8/18/16 |
53462-915-80 |
| 45451 |
7905 |
COMFORT SHIELD 8-PACK |
8/19/16 |
53462-915-80 |
| 45468 |
7905 |
COMFORT SHIELD 8-PACK |
8/20/16 |
53462-915-80 |
| 45483 |
7905 |
COMFORT SHIELD 8-PACK |
8/21/16 |
53462-915-80 |
| 45557 |
7905 |
COMFORT SHIELD 8-PACK |
8/26/16 |
53462-915-80 |
| 45650 |
7905 |
COMFORT SHIELD 8-PACK |
9/2/16 |
53462-915-80 |
| 45768 |
7905 |
COMFORT SHIELD 8-PACK |
9/9/16 |
53462-915-80 |
| 45893 |
7905 |
COMFORT SHIELD 8-PACK |
9/17/16 |
53462-915-80 |
| 45998 |
7905 |
COMFORT SHIELD 8-PACK |
9/23/16 |
53462-915-80 |
| 46169 |
7905 |
COMFORT SHIELD 8-PACK |
10/5/16 |
53462-915-80 |
| 46432 |
7905 |
COMFORT SHIELD 8-PACK |
10/22/16 |
53462-915-80 |
| 46512 |
7905 |
COMFORT SHIELD 8-PACK |
10/27/16 |
53462-915-80 |
| 46551 |
7905 |
COMFORT SHIELD 8-PACK |
10/29/16 |
53462-915-80 |
| 46608 |
7905 |
COMFORT SHIELD 8-PACK |
11/2/16 |
53462-915-80 |
| 46647 |
7905 |
COMFORT SHIELD 8-PACK |
11/4/16 |
53462-915-80 |
| 46669 |
7905 |
COMFORT SHIELD 8-PACK |
11/6/16 |
53462-915-80 |
| 46841 |
7905 |
COMFORT SHIELD 8-PACK |
11/17/16 |
53462-915-80 |
| 46851 |
7905 |
COMFORT SHIELD 8-PACK |
11/17/16 |
53462-915-80 |
| 46970 |
7905 |
COMFORT SHIELD 8-PACK |
11/29/16 |
53462-915-80 |
| 47058 |
7905 |
COMFORT SHIELD 8-PACK |
12/2/16 |
53462-915-80 |
| 47115 |
7905 |
COMFORT SHIELD 8-PACK |
12/7/16 |
53462-915-80 |
| 47202 |
7905 |
COMFORT SHIELD 8-PACK |
12/14/16 |
53462-915-80 |
| 47309 |
7905 |
COMFORT SHIELD 8-PACK |
12/20/16 |
53462-915-80 |
| 47420 |
7905 |
COMFORT SHIELD 8-PACK |
1/8/17 |
53462-915-80 |
| 47436 |
7905 |
COMFORT SHIELD 8-PACK |
1/10/17 |
53462-915-80 |
| 47512 |
7905 |
COMFORT SHIELD 8-PACK |
1/13/17 |
53462-915-80 |
| 47560 |
7905 |
COMFORT SHIELD 8-PACK |
1/17/17 |
53462-915-80 |
| 47800 |
7905 |
COMFORT SHIELD 8-PACK |
2/2/17 |
53462-915-80 |
| 47837 |
7905 |
COMFORT SHIELD 8-PACK |
2/3/17 |
53462-915-80 |
| 48134 |
7905 |
COMFORT SHIELD 8-PACK |
2/19/17 |
53462-915-80 |
| 48154 |
7905 |
COMFORT SHIELD 8-PACK |
2/21/17 |
53462-915-80 |
| 48928 |
7905 |
COMFORT SHIELD 8-PACK |
4/9/17 |
53462-915-80 |
| 48943 |
7905 |
COMFORT SHIELD 8-PACK |
4/11/17 |
53462-915-80 |
| 49149 |
7905 |
COMFORT SHIELD 8-PACK |
4/25/17 |
53462-915-80 |
| 49222 |
7905 |
COMFORT SHIELD 8-PACK |
4/29/17 |
53462-915-80 |
| 49386 |
7905 |
COMFORT SHIELD 8-PACK |
5/9/17 |
53462-915-80 |
| 49466 |
7905 |
COMFORT SHIELD 8-PACK |
5/12/17 |
53462-915-80 |
| 49600 |
7905 |
COMFORT SHIELD 8-PACK |
5/20/17 |
53462-915-80 |
| 49926 |
7905 |
COMFORT SHIELD 8-PACK |
6/13/17 |
53462-915-80 |
| 50578 |
7905 |
COMFORT SHIELD 8-PACK |
7/27/17 |
53462-915-80 |
| 50585 |
7905 |
COMFORT SHIELD 8-PACK |
7/27/17 |
53462-915-80 |
| 50596 |
7905 |
COMFORT SHIELD 8-PACK |
7/28/17 |
53462-915-80 |
| 50600 |
7905 |
COMFORT SHIELD 8-PACK |
7/28/17 |
53462-915-80 |
| 50910 |
7905 |
COMFORT SHIELD 8-PACK |
8/15/17 |
53462-915-80 |
| 51204 |
7905 |
COMFORT SHIELD 8-PACK |
9/6/17 |
53462-915-80 |
| 51260 |
7905 |
COMFORT SHIELD 8-PACK |
9/8/17 |
53462-915-80 |
| 51268 |
7905 |
COMFORT SHIELD 8-PACK |
9/8/17 |
53462-915-80 |
| 51293 |
7905 |
COMFORT SHIELD 8-PACK |
9/9/17 |
53462-915-80 |
| 51344 |
7905 |
COMFORT SHIELD 8-PACK |
9/13/17 |
53462-915-80 |
| 51438 |
7905 |
COMFORT SHIELD 8-PACK |
9/19/17 |
53462-915-80 |
| 51522 |
7905 |
COMFORT SHIELD 8-PACK |
9/23/17 |
53462-915-80 |
| 51527 |
7905 |
COMFORT SHIELD 8-PACK |
9/23/17 |
53462-915-80 |
| 51531 |
7905 |
COMFORT SHIELD 8-PACK |
9/23/17 |
53462-915-80 |
| 51755 |
7905 |
COMFORT SHIELD 8-PACK |
10/7/17 |
53462-915-80 |
| 51824 |
7905 |
COMFORT SHIELD 8-PACK |
10/13/17 |
53462-915-80 |
| 52016 |
7905 |
COMFORT SHIELD 8-PACK |
10/26/17 |
53462-915-80 |
| 52079 |
7905 |
COMFORT SHIELD 8-PACK |
10/29/17 |
53462-915-80 |
| 52083 |
7905 |
COMFORT SHIELD 8-PACK |
10/31/17 |
53462-915-80 |
| 52263 |
7905 |
COMFORT SHIELD 8-PACK |
11/10/17 |
53462-915-80 |
| 52308 |
7905 |
COMFORT SHIELD 8-PACK |
11/14/17 |
53462-915-80 |
| 52397 |
7905 |
COMFORT SHIELD 8-PACK |
11/18/17 |
53462-915-80 |
| 52407 |
7905 |
COMFORT SHIELD 8-PACK |
11/18/17 |
53462-915-80 |
| 52538 |
7905 |
COMFORT SHIELD 8-PACK |
11/29/17 |
53462-915-80 |
| 52614 |
7905 |
COMFORT SHIELD 8-PACK |
12/5/17 |
53462-915-80 |
| 52615 |
7905 |
COMFORT SHIELD 8-PACK |
12/5/17 |
53462-915-80 |
| 52644 |
7905 |
COMFORT SHIELD 8-PACK |
12/6/17 |
53462-915-80 |
| 52659 |
7905 |
COMFORT SHIELD 8-PACK |
12/6/17 |
53462-915-80 |
| 52661 |
7905 |
COMFORT SHIELD 8-PACK |
12/7/17 |
53462-915-80 |
| 52676 |
7905 |
COMFORT SHIELD 8-PACK |
12/7/17 |
53462-915-80 |
| 52737 |
7905 |
COMFORT SHIELD 8-PACK |
12/12/17 |
53462-915-80 |
| 52946 |
7905 |
COMFORT SHIELD 8-PACK |
1/3/18 |
53462-915-80 |
| 53359 |
7905 |
COMFORT SHIELD 8-PACK |
1/25/18 |
53462-915-80 |
| 53624 |
7905 |
COMFORT SHIELD 8-PACK |
2/14/18 |
53462-915-80 |
| 53724 |
7905 |
COMFORT SHIELD 8-PACK |
2/20/18 |
53462-915-80 |
| 53849 |
7905 |
COMFORT SHIELD 8-PACK |
2/27/18 |
53462-915-80 |
| 53850 |
7905 |
COMFORT SHIELD 8-PACK |
2/27/18 |
53462-915-80 |
| 54498 |
7905 |
COMFORT SHIELD 8-PACK |
4/6/18 |
53462-915-80 |
| 54544 |
7905 |
COMFORT SHIELD 8-PACK |
4/10/18 |
53462-915-80 |
| 54653 |
7905 |
COMFORT SHIELD 8-PACK |
4/17/18 |
53462-915-80 |
| 54693 |
7905 |
COMFORT SHIELD 8-PACK |
4/18/18 |
53462-915-80 |
| 54734 |
7905 |
COMFORT SHIELD 8-PACK |
4/20/18 |
53462-915-80 |
| 54769 |
7905 |
COMFORT SHIELD 8-PACK |
4/22/18 |
53462-915-80 |
| 54771 |
7905 |
COMFORT SHIELD 8-PACK |
4/24/18 |
53462-915-80 |
| 54856 |
7905 |
COMFORT SHIELD 8-PACK |
4/28/18 |
53462-915-80 |
| 54922 |
7905 |
COMFORT SHIELD 8-PACK |
5/3/18 |
53462-915-80 |
| 54945 |
7905 |
COMFORT SHIELD 8-PACK |
5/4/18 |
53462-915-80 |
| 55365 |
7905 |
COMFORT SHIELD 8-PACK |
5/30/18 |
53462-915-80 |
| 55629 |
7905 |
COMFORT SHIELD 8-PACK |
6/12/18 |
53462-915-80 |
| 55781 |
7905 |
COMFORT SHIELD 8-PACK |
6/19/18 |
53462-915-80 |
| 56255 |
7905 |
COMFORT SHIELD 8-PACK |
7/18/18 |
53462-915-80 |
| 56263 |
7905 |
COMFORT SHIELD 8-PACK |
7/19/18 |
53462-915-80 |
| 56273 |
7905 |
COMFORT SHIELD 8-PACK |
7/19/18 |
53462-915-80 |
| 56353 |
7905 |
COMFORT SHIELD 8-PACK |
7/24/18 |
53462-915-80 |
| 56410 |
7905 |
COMFORT SHIELD 8-PACK |
7/27/18 |
53462-915-80 |
| 56413 |
7905 |
COMFORT SHIELD 8-PACK |
7/27/18 |
53462-915-80 |
| 56532 |
7905 |
COMFORT SHIELD 8-PACK |
8/3/18 |
53462-915-80 |
| 46225 |
7502 |
COMFORT SHIELD 3-PACK |
10/8/16 |
53462-915-51 |
| 46554 |
7502 |
COMFORT SHIELD 3-PACK |
10/29/16 |
53462-915-51 |
| 46915 |
7502 |
COMFORT SHIELD 3-PACK |
11/22/16 |
53462-915-51 |
| 49296 |
7502 |
COMFORT SHIELD 3-PACK |
5/3/17 |
53462-915-51 |
| 49343 |
7502 |
COMFORT SHIELD 3-PACK |
5/5/17 |
53462-915-51 |
| 50105 |
7502 |
COMFORT SHIELD 3-PACK |
6/23/17 |
53462-915-51 |
| 50626 |
7502 |
COMFORT SHIELD 3-PACK |
7/30/17 |
53462-915-51 |
| 50634 |
7502 |
COMFORT SHIELD 3-PACK |
7/30/17 |
53462-915-51 |
| 50639 |
7502 |
COMFORT SHIELD 3-PACK |
7/30/17 |
53462-915-51 |
| 51310 |
7502 |
COMFORT SHIELD 3-PACK |
9/12/17 |
53462-915-51 |
| 51313 |
7502 |
COMFORT SHIELD 3-PACK |
9/12/17 |
53462-915-51 |
| 51340 |
7502 |
COMFORT SHIELD 3-PACK |
9/13/17 |
53462-915-51 |
| 52388 |
7502 |
COMFORT SHIELD 3-PACK |
11/17/17 |
53462-915-51 |
| 52395 |
7502 |
COMFORT SHIELD 3-PACK |
11/18/17 |
53462-915-51 |
| 52403 |
7502 |
COMFORT SHIELD 3-PACK |
11/18/17 |
53462-915-51 |
| 52421 |
7502 |
COMFORT SHIELD 3-PACK |
11/19/17 |
53462-915-51 |
| 52912 |
7502 |
COMFORT SHIELD 3-PACK |
12/21/17 |
53462-915-51 |
| 52915 |
7502 |
COMFORT SHIELD 3-PACK |
12/22/17 |
53462-915-51 |
| 52918 |
7502 |
COMFORT SHIELD 3-PACK |
12/22/17 |
53462-915-51 |
| 53508 |
7502 |
COMFORT SHIELD 3-PACK |
2/6/18 |
53462-915-51 |
| 54815 |
7502 |
COMFORT SHIELD 3-PACK |
4/26/18 |
53462-915-51 |
| 56307 |
7502 |
COMFORT SHIELD 3-PACK |
7/20/18 |
53462-915-51 |
| 56311 |
7502 |
COMFORT SHIELD 3-PACK |
7/21/18 |
53462-915-51 |
| 56316 |
7502 |
COMFORT SHIELD 3-PACK |
7/21/18 |
53462-915-51 |
| 56457 |
7502 |
COMFORT SHIELD 3-PACK |
7/29/18 |
53462-915-51 |
| 56561 |
7502 |
COMFORT SHIELD 3-PACK |
8/4/18 |
53462-915-51 |
| 53304 |
7508 |
COMFORT SHIELD 8-PACK |
1/23/18 |
53462-915-81 |
| 53339 |
7508 |
COMFORT SHIELD 8-PACK |
1/24/18 |
53462-915-81 |
| 53342 |
7508 |
COMFORT SHIELD 8-PACK |
1/24/18 |
53462-915-81 |
| 53357 |
7508 |
COMFORT SHIELD 8-PACK |
1/25/18 |
53462-915-81 |
| 55784 |
7508 |
COMFORT SHIELD 8-PACK |
6/19/18 |
53462-915-81 |
| 50806 |
7524 |
COMFORT SHIELD 24-PACK |
2/7/17 |
53462-915-60 |
| 52305 |
7524 |
COMFORT SHIELD 24-PACK |
5/15/17 |
53462-915-60 |
| 48066 |
7526 |
COMFORT SHIELD 24-PACK |
8/18/16 |
53462-915-62 |
| 48110 |
7526 |
COMFORT SHIELD 24-PACK |
8/20/16 |
53462-915-62 |
| 48596 |
7526 |
COMFORT SHIELD 24-PACK |
9/20/16 |
53462-915-62 |
| 48668 |
7526 |
COMFORT SHIELD 24-PACK |
9/23/16 |
53462-915-62 |
| 49249 |
7526 |
COMFORT SHIELD 24-PACK |
11/1/16 |
53462-915-62 |
| 49335 |
7526 |
COMFORT SHIELD 24-PACK |
11/4/16 |
53462-915-62 |
| 49535 |
7526 |
COMFORT SHIELD 24-PACK |
11/16/16 |
53462-915-62 |
| 50614 |
7526 |
COMFORT SHIELD 24-PACK |
1/28/17 |
53462-915-62 |
| 50702 |
7526 |
COMFORT SHIELD 24-PACK |
2/2/17 |
53462-915-62 |
| 50988 |
7526 |
COMFORT SHIELD 24-PACK |
2/21/17 |
53462-915-62 |
| 51288 |
7526 |
COMFORT SHIELD 24-PACK |
3/11/17 |
53462-915-62 |
| 51715 |
7526 |
COMFORT SHIELD 24-PACK |
4/6/17 |
53462-915-62 |
| 51745 |
7526 |
COMFORT SHIELD 24-PACK |
4/8/17 |
53462-915-62 |
| 51749 |
7526 |
COMFORT SHIELD 24-PACK |
4/8/17 |
53462-915-62 |
| 51754 |
7526 |
COMFORT SHIELD 24-PACK |
4/8/17 |
53462-915-62 |
| 51765 |
7526 |
COMFORT SHIELD 24-PACK |
4/9/17 |
53462-915-62 |
| 51870 |
7526 |
COMFORT SHIELD 24-PACK |
4/18/17 |
53462-915-62 |
| 52484 |
7526 |
COMFORT SHIELD 24-PACK |
5/26/17 |
53462-915-62 |
| 52864 |
7526 |
COMFORT SHIELD 24-PACK |
6/20/17 |
53462-915-62 |
| 53095 |
7526 |
COMFORT SHIELD 24-PACK |
7/13/17 |
53462-915-62 |
| 53398 |
7526 |
COMFORT SHIELD 24-PACK |
8/1/17 |
53462-915-62 |
| 54081 |
7526 |
COMFORT SHIELD 24-PACK |
9/12/17 |
53462-915-62 |
| 54373 |
7526 |
COMFORT SHIELD 24-PACK |
9/29/17 |
53462-915-62 |
| 55537 |
7526 |
COMFORT SHIELD 24-PACK |
12/7/17 |
53462-915-62 |
| 56020 |
7526 |
COMFORT SHIELD 24-PACK |
1/4/18 |
53462-915-62 |
| 56107 |
7526 |
COMFORT SHIELD 24-PACK |
1/9/18 |
53462-915-62 |
Incontinence Clean-Up Cloth
| Lot # |
Product Code |
Description |
Expiry |
NDC |
| 52588 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 52596 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 52603 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 52607 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 53401 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 53425 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 54432 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
| 55892 |
7505 |
INCONTINENCE CLEAN-UP CLOTH |
N/A - COSMETIC |
N/A |
M-Care™ Meatal Cleansing Cloths for the Foley Catheterized Patient
| Lot # |
Product Code |
Description |
Expiry |
NDC |
| 46651 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 47524 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 49247 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 49782 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 50894 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 50899 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 50904 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 51181 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 52169 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 53283 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 54171 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 54956 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 55721 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 56302 |
7952 |
M-CARE CLEANSING CLOTH 2-PACK |
N/A - COSMETIC |
N/A |
| 47528 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 48233 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 51197 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 52174 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 53297 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 54189 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 55754 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
| 56327 |
7954 |
M-CARE CLEANSING CLOTH 4 2-PACKS |
N/A - COSMETIC |
N/A |
Comfort Bath® Cleansing Washcloths
| Lot # |
Product Code |
Description |
Expiry |
NDC |
| 50777 |
7803 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 50812 |
7803 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 50832 |
7803 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 50852 |
7803 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47226 |
7805 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47972 |
7805 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 48823 |
7805 |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47178 |
7815 |
DEODORANT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47463 |
7815 |
DEODORANT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48186 |
7815 |
DEODORANT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 49194 |
7815 |
DEODORANT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 49181 |
7818 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 46097 |
7855 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47127 |
7855 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47845 |
7855 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48796 |
7855 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48126 |
7856 |
ESSENTIAL BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 49056 |
7856 |
ESSENTIAL BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 51203 |
7856 |
ESSENTIAL BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 52547 |
7856 |
ESSENTIAL BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47899 |
7903 |
COMFORT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 56429 |
7903 |
COMFORT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 46024 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 47290 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 47298 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 48019 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 48862 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 49719 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 49742 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 51277 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 52560 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 53166 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 54080 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 54866 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 54909 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 55627 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 56223 |
7907 |
COMFORT BATH 4-PACK |
N/A - COSMETIC |
N/A |
| 45811 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47167 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47439 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 48169 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 49148 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 51109 |
7942 |
DEODORANT BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 45841 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 47190 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 47471 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 47505 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 48196 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 49208 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 49770 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 50865 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 51139 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 51173 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 52085 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 52117 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 52122 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 52130 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 52137 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 53206 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 53241 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 54114 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 54918 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 55679 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 56256 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 56451 |
7943 |
DEODORANT CLEAN-UP BATH 3-PACK |
N/A - COSMETIC |
N/A |
| 45952 |
7956 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47243 |
7956 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47999 |
7956 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48849 |
7956 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 51263 |
7956 |
COMFORT BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 49128 |
7959 |
BATH CLOTHS 5-PACK |
N/A - COSMETIC |
N/A |
| 46068 |
7982 |
BATH CLOTHS 8-PACK |
N/A - COSMETIC |
N/A |
| 47306 |
7982 |
BATH CLOTHS 8-PACK |
N/A - COSMETIC |
N/A |
| 47818 |
7982 |
BATH CLOTHS 8-PACK |
N/A - COSMETIC |
N/A |
| 48743 |
7982 |
BATH CLOTHS 8-PACK |
N/A - COSMETIC |
N/A |
| 45975 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 46601 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 47263 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48090 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48586 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48693 |
7987 |
IMPREVA BATH 5-PACK |
N/A - COSMETIC |
N/A |
| 48023 |
7988 |
IMPREVA BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 48595 |
7988 |
IMPREVA BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 48649 |
7988 |
IMPREVA BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 51307 |
9775 |
COMFORT BATH 2-PACK |
N/A - COSMETIC |
N/A |
| 54475 |
9775 |
COMFORT BATH 2-PACK |
N/A - COSMETIC |
N/A |
| 47304 |
7800-MC |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 47816 |
7800-MC |
ESSENTIAL BATH 8-PACK |
N/A - COSMETIC |
N/A |
| 53717 |
9702-P |
COMFORT BATH 2-PACK |
N/A - COSMETIC |
N/A |
| 54483 |
9702-P |
COMFORT BATH 2-PACK |
N/A - COSMETIC |
N/A |
2% Chlorhexidine Gluconate Cloths
| Lot # |
Product Code |
Description |
Expiry |
NDC |
| 50749 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
9/29/16 |
53462-705-20 |
| 50765 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
9/30/16 |
53462-705-20 |
| 50771 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
9/30/16 |
53462-705-20 |
| 50773 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
10/1/16 |
53462-705-20 |
| 52839 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
2/9/17 |
53462-705-20 |
| 52843 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
2/9/17 |
53462-705-20 |
| 52855 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
2/10/17 |
53462-705-20 |
| 52861 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
2/10/17 |
53462-705-20 |
| 53840 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
4/21/17 |
53462-705-20 |
| 54760 |
9705 (9701-P) |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
6/15/17 |
53462-705-20 |
| 54763 |
9705 (9780) |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
6/16/17 |
53462-705-20 |
| 56081 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
9/1/17 |
53462-705-20 |
| 56513 |
9705 |
2% CHLORHEXIDINE GLUCONATE 2-PACK |
9/26/17 |
53462-705-20 |
Sage Products is notifying distributors, healthcare facilities, retailers and consumers by letter, and they are being provided instructions to discontinue use and return product to Sage Products.
Customers who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., CDT.
Customers with questions regarding this recall, or requiring replacement product, should call Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., CDT. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online: www.fda.gov/medwatch/report.htm
- Regular mail or fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Media Contacts:
Michael Nygren
Director of Marketing Communications
815-455-4700
[email protected]
About Sage Products
Since 1971, Sage Products has successfully developed and produced innovative prevention products that have significantly improved outcomes for patients and clinicians, while improving efficiency and profitability for healthcare facilities. In 2016, Sage was acquired by Stryker Corporation and is a business within the Stryker Medical Division. Sage is a leading developer of products used to prevent hospital-acquired conditions such as skin injury due to incontinence, pressure ulcers, surgical site infections and healthcare worker injury. To learn more, visit www.sageproducts.com
Company Contact:
Customer Service
1-800-421-6556
SOURCE Sage Products
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