Recall Z-1521-2013— Applied Medical Resources Corp
Class II · Terminated
Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2013-05-01, terminated 2014-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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;.
- Recalling firm
- Applied Medical Resources Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-01
- Terminated
- 2014-02-06
- Firm location
- Rancho Santa Margarita, CA, United States
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;
Data sourced from openFDA. This site is unofficial and independent of the FDA.