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U.S. Department of Health and Human Services

Class 2 Device Recall Pump, blood, extraluminal

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  Class 2 Device Recall Pump, blood, extraluminal see related information
Date Initiated by Firm July 09, 2012
Date Posted August 06, 2012
Recall Status1 Terminated 3 on December 16, 2013
Recall Number Z-2149-2012
Recall Event ID 62563
510(K)Number K961137  
Product Classification Pump, blood, extra-luminal - Product Code FIR
Product Plasma Pump Model PP-04a

Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Code Information D11003544 through D11003552 D11003556 through D11003558
Recalling Firm/
Manufacturer		 Apheresis Technologies, Inc.
612 Florida Ave
Palm Harbor FL 34683-5459
For Additional Information Contact John Cornish
727-787-5616
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 13
Distribution Natonwide Distribution
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.
510(K) Database 510(K)s with Product Code = FIR and Original Applicant = APHERESIS TECHNOLOGIES, INC.
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