FDA Device recall Z-1702-2020
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-s…
- FDA Device
- Class II
- terminated
- Published 2020-04-22
On 2020-04-22 the FDA classified a Class II recall of ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-s… by Merit Medical Systems, citing A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1702-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-09 |
| Published | 2020-04-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Identifiers
| code_info | Merit lot number J559821 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1702-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.