Apheresis Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Apheresis Technologies, Inc. makes
Apheresis Technologies, Inc. manufactures plasma separation systems, including the ATI Plasma Pump (PP-04) for automated apheresis procedures, and plasma discard bags designed for safe disposal of collected plasma during therapeutic apheresis.
The company’s devices are classified as Class II and Unclassified (U) under FDA regulations, with products listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Ati Plasma Pump (Pp-04) Ref K961137
Regimes: 510(k) Registry: 510(k)Plasma Discard Bags Ref K926409
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Apheresis Technologies, Inc., the earliest on 2009-04-01 and the most recent on 2012-07-09. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 9 Jul 2012 Z-2149-2012 Class II Terminated On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a due to a complaint received regarding a rotor of the PP-04a pump that stopped during a therapeutic plasma exchange treatment causing interruption of flow of both the plasma discard line and replacement fruit line.
2010
- 29 Nov 2010 Z-1654-2012 Unclassified (pre-2012) Terminated Apheresis Technologies, Inc., Palm Harbor, FL, initiated a voluntarily withdrawal on November 29, 2010 of their five (5) units of the Plasma Pro Plasma Pump and later classified as a recall (removal) rather than a withdrawal, Model # PP-05, Serial Numbers: E08003041, E08003042, E08003043, E08003044 and E08003045.
2009
- 1 Apr 2009 Z-1897-2009 Unclassified (pre-2012) Terminated Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.
Frequently asked questions
How many devices does Apheresis Technologies, Inc. have in the registry?
The registry currently lists 2 devices for Apheresis Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apheresis Technologies, Inc.'s devices?
Among its 2 most recently registered devices, Apheresis Technologies, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Apheresis Technologies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Apheresis Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Apheresis Technologies, Inc.?
FDA recall records list 3 recalls initiated by Apheresis Technologies, Inc., the most recent initiated on 9 Jul 2012. 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 Apheresis Technologies, Inc. in the registry?
The most recently registered devices listed for Apheresis Technologies, Inc. include ATI PLASMA PUMP (PP-04) and PLASMA DISCARD BAGS.