Recall Z-1868-2012 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
| Date | Jun 26, 2012 (initiated Apr 2, 2012) |
| Status | Terminated |
| Reason | Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. |
| Root cause | Packaging process control |
| Action | MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice. |
| Quantity | 30 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED) Medcomp, May 15, 2007 |