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U.S. Department of Health and Human Services

Class 2 Device Recall Owner Manual for PlasmaPro Plasma Pump

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  Class 2 Device Recall Owner Manual for PlasmaPro Plasma Pump see related information
Date Initiated by Firm April 01, 2009
Date Posted August 27, 2009
Recall Status1 Terminated 3 on July 06, 2010
Recall Number Z-1897-2009
Recall Event ID 52640
510(K)Number K961137  
Product Classification Pump, blood, extra-luminal - Product Code FIR
Product Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging.

Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
Code Information Model PP-05; all units sold.
Recalling Firm/
Manufacturer		 Apheresis Technologies, Inc.
612 Florida Ave
Palm Harbor FL 34683-5459
For Additional Information Contact
727-787-5616
Manufacturer Reason
for Recall		 Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.
FDA Determined
Cause 2		 Labeling design
Action PlasmaPro Plasma Pump Operators Manual was modified and distributed to firms consignees. Firms received written notification of re-issuance of Operator's Manual.
Quantity in Commerce 7 Owner's Manuals
Distribution Nationwide Distribution -- Florida, 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.
510(K) Database 510(K)s with Product Code = FIR and Original Applicant = APHERESIS TECHNOLOGIES, INC.
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