Drug recall
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a…
FDA recall event 79045 · Class II · Smiths Medical ASD, Inc.
Key facts
| Event ID | 79045 |
|---|---|
| Recall numbers | Z-0577-2018 |
| Recalling firm | Smiths Medical ASD, Inc. |
| Product type | Devices |
| Products | Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization. |
| Initiation date | Jul 15, 2016 |
| Report date | Feb 21, 2018 |
| Termination date | Apr 24, 2020 |
| City | Gary |
| State | IN |
| Country | United States |
| FEI number | 1824231 |
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: