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
Code
|
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
mnygren@sageproducts.com
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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/sage-products-expands-voluntary-worldwide-recall-of-specific-lots-of-topical-skin-products-due-to-potential-microbial-contamination-300316125.html
SOURCE Sage Products