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Terminated

PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.

FDA Recall Z-1654-2012 · Posted 2012-05-24

Recalling FirmApheresis Technologies, Inc.
Recall StatusTerminated
Product CodeFIR
Date Initiated2010-11-29
Date Terminated2012-05-25
Product Quantity5 units

Reason for Recall

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.

Firm Action

Apheresis Technologies sent a Letter by FedEx to their two consignees. The letter notified customers of the voluntary recall initiated, affected product and description of the problem. For questions call 727-784-2353 or 1-800-382-5556.

Root Cause

PMA

Distribution Pattern

US Nationwide Distribution including the states of Colorado and Utah.

Official Source

View FDA Recall →

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

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