Drug recall
Applied Medical s Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for…
FDA recall event 65217 · Class II · Applied Medical Resources Corp
Key facts
| Event ID | 65217 |
|---|---|
| Recall numbers | Z-1521-2013 |
| Recalling firm | Applied Medical Resources Corp |
| Product type | Devices |
| Products | Applied Medical s Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 1, 2013 |
| Report date | Jun 19, 2013 |
| Termination date | Feb 6, 2014 |
| City | Rancho Santa Margarita |
| State | CA |
| Country | United States |
| FEI number | 2027111 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: