Advance Medical Designs recalls procedural kits with specific ultrasonic gel item numbers due to mislabeling that could lead to incorrect use. Affected items include models 20-PC424, 20-PC448, 20-PC548, 20-PC596, and 20-PC648 with listed lot numbers.
Ultrasound gel mislabeled with inappropriate use.
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel with specific item numbers because the gel is mislabeled. This mislabeling could lead to incorrect use of the gel during medical procedures, potentially causing harm to patients or the user.
The ultrasonic transmission gel is mislabeled with inappropriate use instructions, which could lead to incorrect application during medical procedures. This might result in ineffective treatment or unintended harm to patients or the user if the gel is used without proper guidance.
Medical professionals and healthcare facilities that purchased the recalled procedural kits with the listed item numbers and lot numbers are most at risk. Patients using the kits may also be affected if the mislabeled gel is used incorrectly.
Check the item numbers on the procedural kits: 20-PC424, 20-PC448, 20-PC548, 20-PC596, or 20-PC648. Also, verify the lot numbers listed for each item number to determine if your kit is affected.
Identify if your procedural kit contains item numbers 20-PC424, 20-PC448, 20-PC548, 20-PC596, or 20-PC648.
The ultrasonic transmission gel is mislabeled with inappropriate use instructions, which could lead to incorrect application during medical procedures.
Item numbers 20-PC424, 20-PC448, 20-PC548, 20-PC596, and 20-PC648 are affected.
Lot numbers for each item number are listed: 21109C2345 for 20-PC424, 30371C3276 for 20-PC448, 21088C2341 and 30353C3268 for 20-PC548, 20622C2244 and 30481C3301 for 20-PC596, and 20145C2088 and 20163C2097 for 20-PC648.
We’ve drafted a message you can send Advance Medical Designs to request your refund or repair — edit it as you like.
Subject: Recall Z-2535-2023 — Advance Medical Designs Advance Medical Designs Hello, I own a Advance Medical Designs that is covered by recall Z-2535-2023 from Advance Medical Designs. 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.
