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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-0860-2009
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: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
Code Information Lot Numbers:  8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271.
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 Commerce351,743 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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