FDA
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
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