PlainRecalls
FDA Drug Moderate Class II Terminated

Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile s

Reported: February 21, 2018 Initiated: August 22, 2017 #D-0411-2018

Product Description

Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9

Reason for Recall

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Details

Recalling Firm
Sage Products Inc
Distribution
Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand
Location
Cary, IL

Frequently Asked Questions

What product was recalled? ▼
Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium Bicarbonate. 1 Bottle of 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w (0.5%available iodine) USP) Patient Preoperative Skin Preparation 0.14 fl oz (4ml), 4 sterile swabs. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 9010 UPC 6 18029 79139 9. Recalled by Sage Products Inc.
Why was this product recalled? ▼
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Moderate. Recall number: D-0411-2018.

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