Recall Z-1527-2015 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Medical Components, Inc dba MedComp
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
| Date | Apr 27, 2015 (initiated Jan 28, 2015) |
| Status | Terminated |
| Reason | The dual port with catheters was not covered under FDA clearance. |
| Root cause | PMA |
| Action | Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. |
| Quantity | 325 |
| Distribution | Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000125 | JET PORT PLUS CATHETER SYSTEM Clinical Plastic Products SA, Apr 12, 2000 |