Recall Z-1635-2024

Reason for recall

Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

FDA-determined cause: Process control

Action taken

Medtronic issued Urgent Medical Device Recall Letter on 3/15/24. Letter states reason for recall, health risk and action to take: 1.Immediately quarantine and discontinue use of unused affected product (see Attachment A). 2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). a.Credit for the returned affected product will be issued based on the RGA number. b. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 3. In addition, please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. 4. This notice should be passed on to those who need to be aware within your organization or to any organization including, but not limited to, nephrologists, intensivists, implanting and managing physicians, renal nurses, critical care nurses, or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. If you have questions regarding this communication, please contact your local representative or Customer Service at 800-962-9888, option 2 (Monday Friday 8:00 a.m. to 6:30 p.m.).