Whatman, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Whatman, Inc. makes
Whatman, Inc. manufactures the NEOCARE 20 MICRON BLOOD FILTER, a device designed for filtering blood during medical procedures to remove particulate matter or clots.
The NEOCARE 20 MICRON BLOOD FILTER is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Neocare 20 Micron Blood Filter Ref K000719
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Whatman, Inc., the earliest on 2009-05-06 and the most recent on 2009-10-29. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 29 Oct 2009 Z-2384-2010 Unclassified (pre-2012) Terminated Neonate newborn screening card demographic and filter portion may be detached
- 19 May 2009 Z-1005-2010 Unclassified (pre-2012) Terminated '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
- 6 May 2009 Z-1871-2009 Unclassified (pre-2012) Terminated The two portions of the card are coming apart prematurely.
Full distribution text
Frequently asked questions
How many devices does Whatman, Inc. have in the registry?
The registry currently lists 1 device for Whatman, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Whatman, Inc.'s devices?
Among its 1 most recently registered device, Whatman, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Whatman, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Whatman, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Whatman, Inc.?
FDA recall records list 3 recalls initiated by Whatman, Inc., the most recent initiated on 29 Oct 2009. 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 Whatman, Inc. in the registry?
The most recently registered devices listed for Whatman, Inc. include NEOCARE 20 MICRON BLOOD FILTER.