Drug recall
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe…
FDA recall event 85206 · Class II · CME America, LLC
Key facts
| Event ID | 85206 |
|---|---|
| Recall numbers | Z-1886-2020 |
| Recalling firm | CME America, LLC |
| Product type | Devices |
| Products | BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The filter installed onto the tube set may have the incorrect pore size. |
| Initiation date | Jan 14, 2020 |
| Report date | May 13, 2020 |
| Termination date | May 27, 2021 |
| City | Golden |
| State | CO |
| Country | United States |
| FEI number | 3006967710 |
At a glance
- 1–9 Products in this recall
- 1–9 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: