Medtronic recalls 6F Launcher Guide Catheter 100 cmJL 3.5 (LA6JL35) due to potential sterility compromise from an unsealed pouch. Affected units sold with lot code 220712186.
Sterility may be compromised due to an unsealed pouch
Medtronic is recalling a specific type of catheter because an unsealed pouch could compromise sterility. This means the device might not be sterile when used, increasing infection risk during medical procedures.
The catheter's pouch may not seal properly, allowing contaminants to enter. This could lead to infections during medical procedures if the device isn't sterile when used.
Healthcare professionals using the catheter for medical procedures are most likely affected. Patients receiving the catheter during procedures could face infection risks if the device isn't sterile.
Check for the model number LA6JL35 on the catheter packaging. Units sold with lot code 220712186 are affected.
Look for the model number LA6JL35 and lot code 220712186 on the catheter packaging.
The recall indicates a potential sterility risk, so it should not be used until the remedy is applied. However, the remedy is not specified in the record.
The official notice does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Check for the model number LA6JL35 and lot code 220712186 on the packaging.
We’ve drafted a message you can send Medtronic Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1245-2021 — Medtronic Vascular Medtronic Vascular Hello, I own a Medtronic Vascular that is covered by recall Z-1245-2021 from Medtronic 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.
