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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, extraluminalsee related information
Date Initiated by FirmJuly 09, 2012
Date PostedAugust 06, 2012
Recall Status1 Terminated 3 on December 16, 2013
Recall NumberZ-2149-2012
Recall Event ID 62563
510(K)NumberK961137 
Product Classification Pump, blood, extra-luminal - Product Code FIR
ProductPlasma 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
FEI Number 1000113717
Recalling Firm/
Manufacturer		 Apheresis Technologies, Inc.
612 Florida Ave
Palm Harbor FL 34683-5459
For Additional Information ContactJohn 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
ActionAPHERESIS 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 Commerce13
DistributionNatonwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FIR
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