Drug recall
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applied s Inzii Tissue Retrieval Bag, Model Number CD004…
FDA recall event 66610 · Class II · Applied Medical Resources Corp
Key facts
| Event ID | 66610 |
|---|---|
| Recall numbers | Z-0183-2014 |
| Recalling firm | Applied Medical Resources Corp |
| Product type | Devices |
| Products | Applied Medical's Inzii¿ 12/15mm Retrieval System. Applied s Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which… |
| Initiation date | Oct 21, 2013 |
| Report date | Nov 20, 2013 |
| Termination date | Sep 15, 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: