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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85171

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 09, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merit Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1702-2020
Recall number
Z-1702-2020
Initiated
July 09, 2018
Classification
Class II
Status
Terminated
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

Code information

Merit lot number J559821

Distribution pattern

US Nationwide distribution in the state of IL. There was no other distribution.