Recall Z-1271-2018 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
| Date | Nov 22, 2017 |
| Status | Terminated |
| Reason | The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire. |
| Root cause | Mixed-up of materials/components |
| Action | Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/ |
| Quantity | 24 Eaches |
| Distribution | CA, AR. AL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT Medcomp ( Medical Components), Dec 12, 2013 |