Drug recall
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health…
FDA recall event 68647 · Class III · Carestream Health Inc.
Key facts
| Event ID | 68647 |
|---|---|
| Recall numbers | Z-2142-2014, Z-2143-2014 |
| Recalling firm | Carestream Health Inc. |
| Product type | Devices |
| Products | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc., Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the… |
| Initiation date | Jul 2, 2014 |
| Report date | Aug 13, 2014 |
| Termination date | May 25, 2016 |
| City | Rochester |
| State | NY |
| Country | United States |
| FEI number | 3006347606 |
At a glance
- 1–9 Products in this recall
- None 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: