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U.S. Department of Health and Human Services

Class 1 Device Recall Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set

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  Class 1 Device Recall Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set see related information
Date Initiated by Firm November 19, 2010
Date Posted January 10, 2011
Recall Status1 Terminated 3 on November 03, 2012
Recall Number Z-0843-2011
Recall Event ID 57293
510(K)Number K962081  
Product Classification Hemodialysis Blood Tubing Set - Product Code FJK
Product Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set
P/N: 03-2695-9
Code Information Lots 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102, 10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
800-662-1237
Manufacturer Reason
for Recall		 Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
FDA Determined
Cause 2		 Device Design
Action Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset¿ BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
Quantity in Commerce 190,080 units (7920 cases x 24 units)
Distribution Distribution Nationwide and Canada
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 = FJK and Original Applicant = NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
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