Epix Universal Clip Applier Recalled for Potential Clip Loading Failure
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm surgical device where the potential malfunction could affect patient care. No illnesses, injuries, or deaths have been reported in the source material. Per the rubric, risk-of-harm products where injury has not yet been reported receive a severity score of at most 3 (High).
Plain-English summary
Applied Medical Resources is recalling the Epix Universal Clip Applier (REF: CA500, STERILEEO) due to a potential malfunction where the device may fail to load the surgical clip after the trigger is actuated. This malfunction could affect the intended surgical procedure.
The affected units were distributed worldwide to healthcare facilities and providers in all regions of the United States and multiple international locations including Canada, Australia, Japan, Germany, France, and other countries.
Healthcare facilities and medical professionals should stop using affected units immediately and contact Applied Medical Resources for instructions regarding device replacement or return.
The recalled product
- Product
- Epix Universal Clip Applier, REF: CA500, STERILEEO
- Manufacturer
- Applied Medical Resources Corp
Distribution
Part of a larger recall action
This product is one of 2 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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