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U.S. Department of Health and Human Services

Class 3 Device Recall Disposable Set for autologous blood cell recovery

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 Class 3 Device Recall Disposable Set for autologous blood cell recoverysee related information
Date Initiated by FirmDecember 17, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on January 28, 2016
Recall NumberZ-0498-03
Recall Event ID 25342
510(K)NumberK932890 
Product Classification Disposable Set for autologous blood cell recovery - Product Code CAC
ProductHaemonetics Cell Saver 5 Fast Pack List Number: 260
Code Information JJ02013 JJ02016 JJ02019 JJ02020 KK02002 KK02004 KK02005 KK02006 KK02007 KK02008 KK02013 KK02016 KK02017 KK02019 KK02021 KK02023 KK02025 LL02002 LL02005 LL02007 LL02008 LL02010 LL02011 LL02013 LL02014 LL02016 LL02017 LL02021 LL02023 LL02024 MM02001 MM02002 MM02003 MM02004 MM02005 MM02006 
Recalling Firm/
Manufacturer		 Haemonetics Corporation
400 Wood Road
Braintree MA 02184
For Additional Information ContactLisa Lopez
781-848-7100
Manufacturer Reason
for Recall		Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
FDA Determined
Cause 2		Other
ActionHaemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
Quantity in Commerce15,150
DistributionNationwide Canada
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 = CAC
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