Recall Z-1223-2018 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cook Vascular Inc.
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
| Date | Nov 28, 2017 |
| Status | Terminated |
| Reason | Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall. |
| Root cause | Nonconforming Material/Component |
| Action | Removal for all non-expired lots of the Cook Vital-Port Vascular Access System. Written recall communication letters will be mailed via courier to US Consignees.plan to STORE recalled product(s)? (if returned) Recalled products will be returned to global regional distribution warehouses to be quarantined in a marked receiving area of returned goods. 8.9 Provide plan for final DISPOSITION for recalled product(s)? All recalled products will be destroyed at the regional distribution warehouses. A certificate of destruction will be provided upon completion of destruction prior to the completion o |
| Quantity | 31,006 Units |
| Distribution | The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Island |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT Cook Vascular, Inc., Sep 30, 2008 |