Applied Medical Resources Corp recalls Epix Universal Clip Appliers (REF: CA500) with STERILEEO included in specific kits. The device may not load clip after trigger actuation. No remedy is listed in the recall notice.
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
Applied Medical Resources Corp is recalling Epix Universal Clip Appliers (model CA500) with STERILEEO included in certain surgical kits. The issue is that the clip may not load properly after the trigger is pressed. This could lead to improper use during procedures, but the recall does not specify a remedy.
The Epix Universal Clip Applier may fail to load the clip after the trigger is pressed. This could result in improper clip application during surgical procedures, potentially affecting the procedure's outcome. However, the risk is not described as causing injury or serious harm.
Surgical professionals and patients who own or use the Epix Universal Clip Applier (CA500) with STERILEEO included in the listed surgical kits are affected. The risk is low as the issue is a potential malfunction during use but not a direct safety hazard.
Check if your Epix Universal Clip Applier (model CA500) with STERILEEO is included in the specific surgical kits listed in the recall notice. The kits have reference numbers like GK1003, AME Kit 54562, and others.
Verify if your Epix Universal Clip Applier (CA500) with STERILEEO is included in the listed surgical kits (reference numbers like GK1003, AME Kit 54562, etc.)
The recall notice does not list any remedy.
The affected kits include reference numbers like GK1003, AME Kit 54562, GK1004, KIT LAP CHOL DEN HOED 2, and others as listed in the recall notice.
The recall states the device may not load the clip after trigger actuation, but it does not describe a risk of injury or serious harm.
We’ve drafted a message you can send Applied Medical Resources Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-1389-2024 — Applied Medical Resources Corp Applied Medical Resources Corp Hello, I own a Applied Medical Resources Corp that is covered by recall Z-1389-2024 from Applied Medical Resources Corp. 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.
