LeMaitre Vascular recalls Pruitt Irrigation Occlusion Catheters with incomplete sterile seals. Affected units have catalog numbers 2102-09 or E2102-09. Contact for remedy.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
LeMaitre Vascular is recalling Pruitt Irrigation Occlusion Catheters that may have incomplete sterile seals. This could lead to contamination during medical procedures. Affected units have specific catalog numbers.
Incomplete sterile seals during manufacturing could allow contaminants to enter the catheter. This poses a risk of infection during medical procedures if the catheter is used without proper sterility.
Healthcare professionals using the catheters for medical procedures. Patients receiving treatments with these catheters are at risk of contamination.
Check for catalog numbers 2102-09 or E2102-09 on the packaging. The catheters have UDI-DI codes starting with 00840663101559 to 00840663101603. Lot numbers with prefixes PIO, QPI, or XPI are affected.
Verify the catalog number and UDI-DI code on the packaging to confirm if the catheter is affected.
Incomplete sterile seals during manufacturing could allow contaminants to enter the catheter, posing a risk of infection during medical procedures.
Check for catalog numbers 2102-09 or E2102-09 on the packaging. Affected units have UDI-DI codes starting with 00840663101559 to 00840663101603.
The recall does not specify a remedy, so contact LeMaitre Vascular directly for guidance.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1752-2025 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-1752-2025 from LeMaitre Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
