Recall Z-1120-2018 ยท NFK Kit, Repair, Catheter, Hemodialysis
Medical Components, Inc dba MedComp
12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli. |
| Root cause | Nonconforming Material/Component |
| Action | On February 23, 2018, Medcomp distributed Product Recall and Distribution notices to international distributors via email and to U.S. facilities via courier service on February 26, 2018. Medcomp is requesting the return of all un-used affected product. Customers should immediately examine inventory and quarantine product subject to recall. If for any reason the product was further distributed, please identify the recipients and notify them at once of this product recall. Your notification may be enhanced by including a copy of this recall notification letter. Contact your customer servic |
| Quantity | 712 kits |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Irela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022570 | MEDCOMP REPAIR KIT, MODEL ASPCRPK Medcomp, Oct 31, 2002 |