[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. — Applied Medical is conducting a voluntary recal
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Applied Medical Resources Corp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1521-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 May 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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;
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Applied Medical Resources Corp
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.