Merit Medical recalls Fountain microcatheter devices (REF: IS4-135-30 and IS4-90-10) due to unguaranteed sterility, which could lead to infections. Affected products include specific lots and UDI numbers.
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Merit Medical is recalling Fountain microcatheter devices because their sterility cannot be guaranteed. This risk could lead to infections if the devices are used in medical procedures.
The devices may not be sterile, which could cause infections during medical procedures. This is a serious risk because medical procedures require sterile conditions to prevent complications.
Healthcare professionals and patients using these devices for medical procedures are affected. Those with the specific lot numbers or UDI codes listed are most at risk.
Check for the product model numbers IS4-135-30 or IS4-90-10. Look for lot numbers H2765720 or H2765603 and UDI codes 00884450000885 or 00884450006504.
Identify the model number, lot number, and UDI code to confirm if your device is affected.
The sterility of the microcatheter and infusion system devices cannot be guaranteed, which could lead to infections during medical procedures.
Check the product details for the model number, lot number, and UDI code to see if it's affected. If it is, contact Merit Medical Systems for further instructions.
Yes, affected products include lot numbers H2765720 and H2765603 with UDI codes 00884450000885 and 00884450006504.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0629-2024 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0629-2024 from Merit Medical Systems. 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.
