Recall Z-1909-2008 ยท DQX Wire, Guide, Catheter
Medical Components, Inc dba MedComp
CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
| Date | Sep 16, 2008 (initiated Apr 11, 2008) |
| Status | Terminated |
| Reason | kit contains incorrect component |
| Root cause | Mixed-up of materials/components |
| Action | The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product. |
| Quantity | 100 units |
| Distribution | The products were shipped to customers in PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031916 | GALT MEDICAL GUIDEWIRE Galt Medical Corp., Jul 17, 2003 |