FDA-Device2020-04-22Class II
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Merit Medical Systems, Inc.
Hazard
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Sold states
US Nationwide distribution in the state of IL. There was no other distribution.
Affected count
6 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2020Don't want to check this manually?
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