Medline recalls MTO Left Heart Kit Model #65021652 sold without sterilization capabilities. Kits intended for sterile use were sold to facilities lacking sterilization equipment, posing infection risks.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Medline is recalling a specific left heart kit used in cath labs and interventional radiology. These kits were sold to facilities that don't have the ability to sterilize them properly, which could lead to infections if used without sterilization.
The kits are designed to be sterile but were sold to facilities that cannot sterilize them. This means the kits may not be sterile when used, potentially causing infections in patients.
Healthcare facilities using this specific kit model for catheter labs or interventional radiology procedures. Facilities without sterilization equipment are most at risk.
Check for the model number 65021652 on the kit. The kits were sold to healthcare facilities with the product usage specified as NAMIC Cath Lab and Interventional Radiology. Lot 5574586 with an expiration date of January 31, 2023.
Identify the model number on the kit to confirm it is 65021652.
Ensure your facility has the ability to sterilize the kit before use.
The kits were sold to healthcare facilities that cannot sterilize them properly, which could lead to infections if used without sterilization.
The model number is 65021652.
The expiration date is January 31, 2023.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0061-2021 — Medline Medline Hello, I own a Medline that is covered by recall Z-0061-2021 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.
