Symbios Medical Products, LLC
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Symbios Medical Products, LLC makes
Symbios Medical Products, LLC manufactures disposable infusion pump kits, including the Go Pump Rapid Recovery System and standard disposable infusion pump kits. The company also provides modifications to these infusion pump kits, designed for controlled administration of fluids or medications in clinical settings.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Symbios Disposable Infusion Pump Kit Ref K051474
Regimes: 510(k) Registry: 510(k)Modification To Disposable Infusion Pump Kit Ref K071735
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 12 recalls initiated by Symbios Medical Products, LLC, the earliest on 2013-02-25 and the most recent on 2013-05-10. By recorded status: 12 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 10 May 2013 Z-1452-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1453-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1454-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1455-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1456-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1457-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1458-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1459-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1460-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 10 May 2013 Z-1461-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Show all 12 recalls
2013
- 10 May 2013 Z-1462-2013 Class I Terminated Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
- 25 Feb 2013 Z-0940-2013 Class I Terminated Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
Frequently asked questions
How many devices does Symbios Medical Products, LLC have in the registry?
The registry currently lists 3 devices for Symbios Medical Products, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Symbios Medical Products, LLC's devices?
Among its 3 most recently registered devices, Symbios Medical Products, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Symbios Medical Products, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Symbios Medical Products, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Symbios Medical Products, LLC?
FDA recall records list 12 recalls initiated by Symbios Medical Products, LLC, the most recent initiated on 10 May 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Symbios Medical Products, LLC in the registry?
The most recently registered devices listed for Symbios Medical Products, LLC include DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM, SYMBIOS DISPOSABLE INFUSION PUMP KIT and MODIFICATION TO DISPOSABLE INFUSION PUMP KIT.