LeMaitre Vascular recalls 35cc syringes with ISO 594 female luer lock due to potential particulate contamination in packaging foam that could affect sterile procedures.
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
LeMaitre Vascular is recalling 35 cc syringes with ISO 594 female luer locks because packaging foam may contain particles that could contaminate sterile medical fields during use. This risk could lead to infections or complications during angiographic procedures.
Packaging foam in the syringes may contain particles that could contaminate the sterile field during medical procedures. This contamination might lead to infections or complications if the syringes are used without proper cleaning.
Healthcare professionals using these syringes for angiographic procedures are most at risk. Patients receiving contrast media injections during these procedures may also be affected.
Check for syringes with the catalog number 4100-00 and lots LCI1091 through LCI1099. These were sold for angiographic procedures using contrast media.
Identify the lot number on the syringe packaging to determine if it is in the affected range (LCI1091 to LCI1099).
The recall addresses potential particulate contamination in packaging foam that could affect sterile procedures, but the risk is considered low as it does not involve immediate harm.
Look for syringes with catalog number 4100-00 and lot numbers LCI1091 through LCI1099.
The recall does not specify a remedy, so you should check the lot number and contact LeMaitre Vascular if you have concerns.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1529-2021 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-1529-2021 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.
