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
2102-09E2102-09
- Lot codes and dates
- UDI-DI
008406631015800084066310155900840663101566008406631015970084066310157300840663101603
- Catalog Numbers
2102-09E2102-09. Lot
- not expired with the following prefixPIO, QPI, XPI
- UDI-DI
- 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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