Symbios Medical Products, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (12 Class I)
- 510(k) Clearances
- 3
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1457-2013 | Class I | Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the follo | May 10, 2013 |
| Z-1459-2013 | Class I | Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... | May 10, 2013 |
| Z-1455-2013 | Class I | Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in th | May 10, 2013 |
| Z-1453-2013 | Class I | Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side, | May 10, 2013 |
| Z-1458-2013 | Class I | Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the foll | May 10, 2013 |
| Z-1461-2013 | Class I | Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found | May 10, 2013 |
| Z-1460-2013 | Class I | Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found | May 10, 2013 |
| Z-1462-2013 | Class I | Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. | May 10, 2013 |
| Z-1454-2013 | Class I | Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : Go | May 10, 2013 |
| Z-1452-2013 | Class I | Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr c | May 10, 2013 |
| Z-1456-2013 | Class I | Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the fo | May 10, 2013 |
| Z-0940-2013 | Class I | GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part | February 25, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | November 26, 2007 |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | July 19, 2007 |
| K051474 | SYMBIOS DISPOSABLE INFUSION PUMP KIT | July 1, 2005 |