First Medical Source, LLC
Country not established FDA establishment FEI 3007008418
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 1
Catalogue
- GUDID
- GUDID
InfuLife Ref K240624
510(k) 510(k)
Company details
- FDA FEI number
- 3007008418
- Address
- 28581 Springfield Drive, Laguna Beach, CA, 92677
FDA recalls
2011
- 9 Jul 2011 Z-0161-2013 Class I Terminated Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The pr
Frequently asked questions
How many devices does FIRST MEDICAL SOURCE, LLC have in the registry?
The registry currently lists 3 devices for FIRST MEDICAL SOURCE, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list FIRST MEDICAL SOURCE, LLC's devices?
Among its 3 most recently registered devices, FIRST MEDICAL SOURCE, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do FIRST MEDICAL SOURCE, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for FIRST MEDICAL SOURCE, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for FIRST MEDICAL SOURCE, LLC?
FDA recall records list 1 recall initiated by FIRST MEDICAL SOURCE, LLC, the most recent initiated on 2011-07-09. 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 FIRST MEDICAL SOURCE, LLC in the registry?
The most recently registered devices listed for FIRST MEDICAL SOURCE, LLC include First Medical Source (FMS) YC50, First Medical Source (FMS) SC50 and InfuLife.