FDA recall Z-1702-2020

Merit Medical Systems, Inc. · Class II · device

Product

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.

Reason for recall

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

Distribution

US Nationwide distribution in the state of IL. There was no other distribution.

Key facts

Status
Terminated
Initiation date
2018-07-09
Report date
2020-04-22
Termination date
2020-04-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2020