Recall Z-2536-2015 ยท NGT Saline, Vascular Access Flush
Covidien LLC
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
| Date | Sep 1, 2015 (initiated Aug 6, 2015) |
| Status | Terminated |
| Reason | Sterility may be compromised |
| Root cause | Packaging process control |
| Action | Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878 |
| Quantity | 325 KITS |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060339 | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY Tyco Healthcare/Kendall, Apr 28, 2006 |