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U.S. Department of Health and Human Services

Class 2 Device Recall CombiSet True Flow Series

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 Class 2 Device Recall CombiSet True Flow Seriessee related information
Date Initiated by FirmNovember 25, 2008
Date PostedJanuary 23, 2009
Recall Status1 Terminated 3 on September 24, 2009
Recall NumberZ-0859-2009
Recall Event ID 50491
510(K)NumberK022536 
Product Classification Hemodialysis Blood Circuit and Accessories - Product Code KOC
ProductCombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
Code Information Lot number 8LR902 only
Recalling Firm/
Manufacturer		 Fresenius Medical Care North America
920 Winter St
Waltham MA 02451-1521
For Additional Information ContactSAME
800-662-1237
Manufacturer Reason
for Recall		Port may crack and separate resulting in potential blood exposure/blood loss for the patient
FDA Determined
Cause 2		Process control
ActionFresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.
Quantity in Commerce57 units
DistributionWorldwide Distribution --- including USA and country of 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 = KOC
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