Hsmg, Inc. D/b/a Smartinfuser USA
Houston, TX
Hsmg, Inc. D/b/a Smartinfuser Usa appears in FDA device records in Houston, TX. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 4
- Registered establishments
- 0
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
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1982-2011 | SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD. | Elastomeric tube in product's compression unit has the potential to burst following filling. | Terminated | ||
| Z-1981-2011 | SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. | Elastomeric tube in product's compression unit has the potential to burst following filling. | Terminated | ||
| Z-1022-2010 | SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. | Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature. | Terminated | ||
| Z-1021-2010 | SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. | Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain