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U.S. Department of Health and Human Services

Class 2 Device Recall NexSite" HD Hemodialysis Symmetric Tip Catheter

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  Class 2 Device Recall NexSite" HD Hemodialysis Symmetric Tip Catheter see related information
Date Initiated by Firm February 11, 2020
Create Date June 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-1699-2021
Recall Event ID 87827
510(K)Number K173805  
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
Product NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Code Information Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378; NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380; NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435;
Recalling Firm/
Manufacturer		 MARVAO MEDICAL DEVICES LTD.
Unit 1 Galway Business Park
Dangan
Galway Ireland
For Additional Information Contact Chris Davey
855-2100554 Ext. 114
Manufacturer Reason
for Recall		 The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
FDA Determined
Cause 2		 Labeling Change Control
Action On 02/10/2020, the firm emailed a "Direction For Use Update" Letter, to inform them that the firm has updated its Directions for Use (LS 122) from revision 01 to revision 02 and stated that the update is to provide clarification of an existing warning following a complaint where the stylet hub detached following removal without a guidewire in place. The updated DFU now includes the following statement, "The stylet is not to be removed without the guidewire in place. To remove the stylet forcibly in such cases could result in device damage". Customer are begin informed that the Recalling Firm will be removing LS 122 revision 01 which they currently have and replace it with LS 122 revision 02. This "rework" (replacement) will be conducted by the Recalling Firm's distributor DirectACCESS. The rework (replacement) will occur by the end of March 2020. A copy of the DFU is provided on the Recalling Firm's website and is also attached to the customer notification email. For questions associated with this correction - contact Recalling Firm at: Telephone number - +353 (0) 91 759 301 email - chris.davey@marvaomedical.com or, DirectACCESS at (855)210-0554 Ext 114
Quantity in Commerce 292 devices
Distribution U.S.: CO, NC, SC, TX, O.U.S.: Not provided
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MSD and Original Applicant = Marvao Medical Devices, Ltd.
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