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U.S. Department of Health and Human Services

Class 2 Device Recall PlasmaPro Plasma Pump

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  Class 2 Device Recall PlasmaPro Plasma Pump see related information
Date Initiated by Firm November 29, 2010
Date Posted May 24, 2012
Recall Status1 Terminated 3 on May 25, 2012
Recall Number Z-1654-2012
Recall Event ID 61621
Product Classification Pump, blood, extra-luminal - Product Code FIR
Product 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.
Code Information Model PP-05; Serial Numbers E08003041, E08003042, E08003043, E08003044, and E08003045,
Recalling Firm/
Manufacturer		 Apheresis Technologies, Inc.
612 Florida Ave
Palm Harbor FL 34683-5459
For Additional Information Contact John B. Cornish
727-784-2353
Manufacturer 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.
FDA Determined
Cause 2		 PMA
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.
Quantity in Commerce 5 units
Distribution US Nationwide Distribution including the states of Colorado and Utah.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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