Amsino Healthcare (USA) Inc.
Vernon Hills, IL, US
Amsino Healthcare (USA) Inc. appears in FDA device records in Vernon Hills, IL. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 14 recalls 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 Amsino Healthcare (USA) Inc. 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.
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Companyenforcement 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 |
|---|---|---|---|---|---|
| 1417519 | 1417519 | Amsino Healthcare (USA) Inc. | 330 CORPORATE WOODS PARKWAY, Vernon Hills, IL 60061 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-0490-2019 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Terminated | |
| Z-0722-2019 | Medline Prefilled 550 ml Sterile | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0721-2019 | Portex 5ml Normal Saline (0.9%) Unit Dose | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0720-2019 | Portex Unit Dose 15 ml Normal Saline | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0719-2019 | Portex Unit Dose 5 ml Normal Saline (0.9%) | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0718-2019 | Medline Prefilled 350 ml Sterile | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0717-2019 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0716-2019 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0715-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0714-2019 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0713-2019 | Portex 500 ml Sterile Water USP Pour Bottle | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0712-2019 | Portex 1000 ml Sterile Water USP Pour Bottle | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0711-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated | |
| Z-0710-2019 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt. | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain