Drug recall
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile…
FDA recall event 75781 · Class II · Teleflex Medical
Key facts
| Event ID | 75781 |
|---|---|
| Recall numbers | Z-0771-2017 |
| Recalling firm | Teleflex Medical |
| Product type | Devices |
| Products | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. |
| Initiation date | Nov 22, 2016 |
| Report date | Dec 28, 2016 |
| Termination date | Nov 24, 2017 |
| City | Research Triangle Park |
| State | NC |
| Country | United States |
| FEI number | 1044475 |
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: