PlainRecalls
FDA Devices Moderate Class II Terminated

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

Reported: June 19, 2013 Initiated: May 1, 2013 #Z-1521-2013

Product Description

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

Reason for Recall

Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;

Details

Units Affected
127,305 units
Distribution
Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.
Location
Rancho Santa Margarita, CA

Frequently Asked Questions

What product was recalled? ▼
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.. Recalled by Applied Medical Resources Corp. Units affected: 127,305 units.
Why was this product recalled? ▼
Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enough force is applied, there is a potential for the trigger to fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result in permanent patient injury is highly unlikely;
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2013. Severity: Moderate. Recall number: Z-1521-2013.

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