• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics cardioPAT System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Haemonetics cardioPAT System
see related information
Date Posted December 08, 2007
Recall Status1 Open
Recall Number Z-0358-2008
Recall Event ID 45427
Premarket Notification
510(K) Number
K053000 
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
Code Information All Serial numbers
Recalling Firm/
Manufacturer
Haemonetics Corporation
400 Wood Rd
Braintree, Massachusetts 02184-2412
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.
Quantity in Commerce 106 units
Distribution Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA
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.
-
-