Z-1702-2020 Class II Terminated
FDA device recall Z-1702-2020 was initiated by Merit Medical Systems, Inc. on Jul 9, 2018 and is designated Class II. Reason for recall: A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. The recall status is terminated (terminated Apr 14, 2020). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 22, 2020
- Initiation Date
- Jul 9, 2018
- Termination Date
- Apr 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
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 Pattern
US Nationwide distribution in the state of IL. There was no other distribution.
Code Information
Merit lot number J559821
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1702-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026