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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System

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 Class 2 Recall
Haemonetics cardioPAT Cardiovascular Perioperative Autotransfusion System
see related information
Date Posted August 05, 2011
Recall Status1 Terminated on June 09, 2014
Recall Number Z-2956-2011
Recall Event ID 59379
Premarket Notification
510(K) Number
K053000 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics® Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Haemonetics Corporation
400 Wood Rd
Braintree, Massachusetts 02184-2412
For Additional Information Contact SAME
781-848-7100
Manufacturer Reason
for Recall
Updated Operations Manual for the deployment of the spill collection system and cleaning
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Haemonetics sent a "FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and Quick Reference Guide Addendum are enclosed with the letter. Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..
Quantity in Commerce 316 units
Distribution Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = HAEMONETICS CORP.
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