Drug recall
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA…
FDA recall event 62705 · Class II · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Event ID | 62705 |
|---|---|
| Recall numbers | Z-2301-2012 |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Product type | Devices |
| Products | DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP… |
| Initiation date | Aug 1, 2012 |
| Report date | Sep 5, 2012 |
| Termination date | Sep 6, 2013 |
| City | Boulder |
| State | CO |
| Country | United States |
| FEI number | 2936999 |
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: