Pall Corp.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Pall Supor Aef Filter Ref K993379
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
2014
- 4 Jun 2014 Z-2038-2014 Class II Terminated Possible leak from the filter allowing a small of amount of air to be released from the junction between the filter end cap (flat side of the filter) and the filter housing connection.
2011
- 26 May 2011 Z-2856-2011 Unclassified (pre-2012) Terminated Potential for the housing of the arterial line Leukocyte Reduction Filter to separate before or during the priming procedure.
Frequently asked questions
How many devices does Pall Corp. have in the registry?
The registry currently lists 4 devices for Pall Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pall Corp.'s devices?
Among its 4 most recently registered devices, Pall Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Pall Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Pall Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pall Corp.?
FDA recall records list 2 recalls initiated by Pall Corp., the most recent initiated on 4 Jun 2014. 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 Pall Corp. in the registry?
The most recently registered devices listed for Pall Corp. include PALL SUPOR AEF FILTER, PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM, Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger and PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE.