Drug recall
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally…
FDA recall event 63842 · Class II · Applied Medical Resources Corp
Key facts
| Event ID | 63842 |
|---|---|
| Recall numbers | Z-0644-2013 |
| Recalling firm | Applied Medical Resources Corp |
| Product type | Devices |
| Products | Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield… |
| Initiation date | Nov 5, 2012 |
| Report date | Jan 16, 2013 |
| Termination date | Jan 16, 2013 |
| 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: