Reported May 21, 2025 · Ongoing

Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

LeMaitre Vascular, Inc.

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: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414

Is this the product you have?

  • Pruitt Irrigation Occlusion Catheter
  • Catalog Numbers
    • 2102-09
    • E2102-09
Lot codes and dates
  • UDI-DI
    • 00840663101580
    • 00840663101559
    • 00840663101566
    • 00840663101597
    • 00840663101573
    • 00840663101603
  • Catalog Numbers
    • 2102-09
    • E2102-09. Lot
  • not expired with the following prefixPIO, QPI, XPI
Amount recalled
26,872 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new packaged foods recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 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.