Surge Medical Sales, LLC (dba Surge Cardiovascular)
Grand Rapids, MI, US
Surge Medical Sales, LLC (DBA Surge Cardiovascular) appears in FDA device records in Grand Rapids, MI. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 6
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to Surge Medical Sales, LLC (dba Surge Cardiovascular) 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.
- Alliant Enterprises LLCrecall
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-0068-2019 | Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. | The device was built with the rigid insertion stylet instead of the flexible stylet. | Class II | Terminated | |
| Z-3062-2011 | TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION: TUBING W/ ONE WAY VALVE, STERILE The TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. | Terminated | ||
| Z-3061-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25, DESCRIPTION: NONADJUSTABLE VENT VALVE, STERILE The TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. | Terminated | ||
| Z-3060-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUANTITY: 100, DESCRIPTION: NONADJUSTABLE VENT VALVE, NON-STERILE; AND and 3-T Medical Systems, Catalog #035NS, Non-Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE The TrueChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. | Terminated | ||
| Z-3059-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: 100 DESCRIPTION: ADJUSTABLE VENT VALVE, NON-STERILE; and 3T Medical Systems Catalog# 030NS Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE The TruChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. | Terminated | ||
| Z-3058-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 25 DESCRIPTION: ADJUSTABLE VENT VALVE, STERILE The TruChoice Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart. | The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain