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.
FDA Recall Z-1702-2020 · Posted None
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeOEQ
Date Initiated2018-07-09
Date Terminated2020-04-14
Product Quantity6 units
Reason for Recall
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Firm Action
The firm immediately notified the customer on 7/9/2018 to determine if the product had been used.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the state of IL. There was no other distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.