Recall Z-1910-2008 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Medical Components, Inc dba MedComp
USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system.
| 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 | 250 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
| K053345 | PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D Medcomp, Mar 17, 2006 |