Medline recalls specific cath lab kits sold without sterilization capabilities. Kits intended for sterile use were sold to facilities 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 a specific catheter lab kit model that was sold to facilities without sterilization equipment. This poses a risk of infection because the kits are designed to be sterile but were not properly sterilized before use.
These kits are designed to be sterilized before use to prevent infection. However, they were sold to facilities that lack the ability to sterilize them, increasing the risk of infection during medical procedures.
Healthcare facilities using catheter lab kits with this model number are affected. Facilities without sterilization capabilities are at higher risk due to the potential for infection.
Check for the model number 650305414 on the kit. The kits are used in catheter labs and interventional radiology procedures. They were sold without a lot number or expiration date.
Identify the model number on the kit to confirm if it matches 650305414.
The kits were sold to facilities without sterilization capabilities, even though they are designed to be sterilized before use.
The risk is infection due to the kits not being properly sterilized before medical procedures.
Look for the model number 650305414 on the kit, which is used in catheter labs and interventional radiology procedures.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2021 — Medline Medline Hello, I own a Medline that is covered by recall Z-0065-2021 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.
