Recall Z-1699-2021 ยท MSD Catheter, Hemodialysis, Implanted
MARVAO MEDICAL DEVICES LTD.
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
| Date | Feb 11, 2020 |
| Status | Open, Classified |
| Reason | The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website. |
| Root cause | 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 Fir |
| Quantity | 292 devices |
| Distribution | U.S.: CO, NC, SC, TX, O.U.S.: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter Marvao Medical Devices, Ltd., Feb 8, 2018 |