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Terminated

Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.

FDA Recall Z-2149-2012 · Posted 2012-08-06

Recalling FirmApheresis Technologies, Inc.
Recall StatusTerminated
Product CodeFIR
Date Initiated2012-07-09
Date Terminated2013-12-16
Product Quantity13

Reason for Recall

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.

Firm Action

APHERESIS TECHNOLOGIES, INC. sent a letter dated July 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the device for repair. For questions customers should call 727-787-5616.

Root Cause

Process control

Distribution Pattern

Natonwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961137ATI PLASMA PUMP (PP-04)Apheresis Technologies, Inc. · 1996-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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