Home › Gilero, LLC › BD SmartSite Bag 100mL
BD SmartSite Bag 100mL
Gilero, LLC · Model 11365-325-18 · UDI-DI 00382902001003
KPE
Prescription
10
510(k) clearances
6,805
Adverse events (8 deaths)
62
Recalls
85
Facilities
Description
The SmartSite Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.