Reported Jul 10, 2024 · Ongoing

Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component…

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Sterile surgical convenience kitMedline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile
Lot codes and dates
    • Pack #DYNJ56073C - lot numbers 23IDA509
    • exp. 5/31/2026
    • and 23DDC159
    • exp. 11/30/2025
    • UDI-DI each-10193489441833
    • UDI-DI case-40193489441834
Amount recalled
12,588 total sterile kits

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.