Applied Medical Resources Recalls Epix Universal Clip Applier Kits
Applied Medical Resources is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier kits, including models STD GK258 AME Standard Kit 44, STD KIT GK213 AME Standard Kit 15, and STD KIT GK260 Standard Set 360 Z. The recall is being conducted because of a potential loading mechanism nonconformance in the affected CA500 lot.
The affected product is a disposable laparoscopic clip applier indicated for the ligation of tubable structures or vessels in laparoscopic and general surgical procedures. The specific lot number involved in this recall is 1239287.
The product was distributed nationwide in the United States to the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. It was also distributed to foreign countries including Austria, Belgium, Denmark, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, and Great Britain.
The recalled product
- Product
- STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
- Manufacturer
- Applied Medical Resources Corp
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 1239287
Distribution
Part of a larger recall action
This product is one of 4 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.
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