US Infusion LLC. D/B/a Truecare Biomedix-USA
South Miami, FL, US
US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA appears in FDA device records in South Miami, FL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to US Infusion LLC. D/B/a Truecare Biomedix-USA carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- US Infusion Inc dba Trucare Biomedix-USAenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008782867 | 3008782867 | US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA | 6356 Manor Ln Ste 101, South Miami, FL 33143 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1277-2015 | Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date. | Several complaints regarding the IV sets leaking at the Y site. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain