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EPIX UNIVERSAL CLIP APPLIER (2015-12-23)
- Starting date:
- December 23, 2015
- Posting date:
- January 25, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56818
Affected Products
EPIX UNIVERSAL CLIP APPLIER
Reason
Applied Medical is conducting a voluntary recall of one specific lot of the CA500 Epix universal clip applier due to a potential loading mechanism non-conformance. This may lead to clips not loading into the jaws, requiring the user to actuate the trigger again to load a clip as per the instructions for use. Patient harm is unlikely if the device is used as indicated in the instructions for use.
Affected products
EPIX UNIVERSAL CLIP APPLIER
Lot or serial number
1231562
Model or catalog number
CA500
Companies
- Manufacturer
-
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita
California
UNITED STATES