FDA recall D-0411-2018

Product

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

Distribution

Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand

Key facts

Status

Terminated

Initiation date

2017-08-22

Report date

2018-02-21

Termination date

2018-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cary, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0411-2018