Medline recalls MTO Left Heart Kit Model #65193091 sold without sterilization capabilities. Kits intended for sterile use were sold to accounts lacking sterilization equipment, risking infection.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Medline is recalling MTO Left Heart Kits that were sold without sterilization capabilities. These kits are meant to be sterilized before use but were sold to customers who don't have the equipment to do so, increasing infection risk.
The kits are designed to be sterile but were sold to accounts that cannot perform sterilization. This means the kits may not be sterile when used, potentially causing infections in patients or healthcare workers.
Healthcare facilities using these kits for catheter labs or interventional radiology procedures are affected. Staff and patients at facilities without sterilization equipment are at higher risk of infection.
Check for the model number 65193091 on the kit. These kits were sold with lot number 5619215 and expire June 30, 2023.
Identify the model number on the kit to confirm it is 65193091.
The kits were sold to accounts without sterilization capabilities, but they are designed to be sterilized before use.
The kits may not be sterile when used, increasing the risk of infection for patients and healthcare workers.
Look for model number 65193091 and lot number 5619215 on the kit, which expires June 30, 2023.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0068-2021 — Medline Medline Hello, I own a Medline that is covered by recall Z-0068-2021 from Medline. 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.
