Recall Z-2235-2010 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
| Date | Aug 17, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port. |
| Root cause | Employee error |
| Action | Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp. |
| Quantity | 47 units |
| Distribution | Worldwide Distribution -- USA, including states of NC and TX and country of Israel. |
| 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 |