Smiths Medical recalls medfusion Stopcock 1-way and 4-way models with specific model and serial numbers due to lack of sterility assurance. Affected users should check their product details and contact Smiths Medical for guidance.
Product has a lack of sterility assurance
Smiths Medical is recalling certain medfusion Stopcock devices because they lack sterility assurance. This means the products could be contaminated, posing a risk of infection during medical procedures.
The stopcocks may not maintain sterility, which could lead to contamination during medical procedures. This risk is primarily for devices used in sterile environments like hospitals or clinics.
Healthcare professionals and patients using the recalled medfusion Stopcock devices for medical procedures. Those with the specific model numbers and serial numbers listed are most at risk.
Check the model number on the stopcock (e.g., 081-101BE) and the serial number listed in the recall notice. The recall includes specific model numbers and their corresponding serial numbers.
Identify the model number and serial number on your medfusion Stopcock device to see if it matches the recalled items listed in the notice.
The recall is due to a lack of sterility assurance, which could lead to contamination during medical procedures.
The affected model numbers include 081-101BE, 081-101GE, 081-101GEE, 081-101NE, and others as listed in the recall notice.
The recall does not require immediate discontinuation; users should check their product details and contact Smiths Medical for further guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0155-2022 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0155-2022 from Smiths Medical. 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.
