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U.S. Department of Health and Human Services

Class 2 Device Recall Haemonetics

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  Class 2 Device Recall Haemonetics see related information
Date Initiated by Firm July 22, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on May 24, 2012
Recall Number Z-0174-06
Recall Event ID 32844
510(K)Number K043127  
Product Classification Apparatus, Autotransfusion - Product Code CAC
Product cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E
and Disposables:
cardioPAT Replacement RBC Bags, LN 00270
cardioPAT Replacement Waste Bags, LN 00271
cardioPAT Replacement Intraoperative Suction Set, LN 00272
cardioPAT Replacement Postoperative Suction Set, LN 00273
cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274
cardioPAT Replacement One-Way Valve Assembly LN 00275
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Rd
Braintree MA 02184-2412
For Additional Information Contact
781-356-9488
Manufacturer Reason
for Recall		 Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System
FDA Determined
Cause 2		 Other
Action Haemonetics issued a recall notification via Certified Mail on 7/22/05 to four user sites requesting return of the machine and all disposables received.
Quantity in Commerce 4 machines and 486 disposables
Distribution CA, MN, NE, TX
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 = CAC and Original Applicant = HAEMONETICS CORP.
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