The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1702-2020·Announced 2020-04-22

Merit Medical Recalls Nonsterile ChloraPrep Applicators for Vein Trays

Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a shipping error involving a nonsterile bulk product without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Merit Medical Systems, Inc. is recalling six units of 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. These products are components of the Vein Tray K12T-10167. The recall involves Merit lot number J559821.

The recall was initiated because a nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. The distribution was limited to the state of Illinois, with no other distribution reported.

Consumers and healthcare facilities in Illinois who possess this specific lot of ChloraPrep applicators should stop using the product and contact Merit Medical Systems for further instructions.

The recalled product

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…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Surgical Skin Preparation
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Merit lot number J559821

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls