LeMaitre Vascular recalls sterile polyurethane carotid shunt model 2014-10 (lot PFP1055) due to unsealed pouches risking infection. Affected units expire March 2020.
Pouches from this lot are not sealed compromising the sterility
LeMaitre Vascular is recalling a specific sterile carotid shunt model because pouches from this batch aren't sealed properly. This could allow infection since the device is meant to be sterile during medical procedures.
The pouches aren't sealed properly, which means bacteria could enter the sterile device. This is dangerous because the shunt is used in delicate medical procedures where infection could cause serious complications.
Patients who received this specific shunt model (2014-10, lot PFP1055) from LeMaitre Vascular. Medical professionals using this model during procedures are at risk if the pouch isn't sealed.
Check for the model number 2014-10 and lot number PFP1055 on the shunt packaging. The expiration date is March 2020.
Look for model number 2014-10 and lot number PFP1055 on the shunt packaging.
The shunt is not safe to use as the pouches may not be sealed, risking infection. Affected units should be checked and handled carefully.
Check the model number and lot number on the packaging. If it matches 2014-10 and PFP1055, contact LeMaitre Vascular for guidance.
Look for model number 2014-10 and lot number PFP1055 on the shunt packaging. The expiration date is March 2020.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0473-2019 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-0473-2019 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.
