Z-1702-2020Class II

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient...

Name: Z-1702-2020 ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient...
Creator: Merit Medical Systems, Inc.
Published: 2018-07-09
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2018-07-09 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution... on 2018-07-09. FDA classified it as Class II and gives the reason as "A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1702-2020
Classification: Class II
Status: Terminated
Initiated: 2018-07-09
Posted: 2020-04-13
Terminated: 2020-04-14
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm immediately notified the customer on 7/9/2018 to determine if the product had been used.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the state of IL. There was no other distribution.
Product codes and lots: Merit lot number J559821

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-13

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)