Recall Z-1005-2015 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or
| Date | Jan 22, 2015 (initiated Dec 16, 2014) |
| Status | Terminated |
| Reason | the Instructions for Use (IFU) were inadvertently removed from the kit. |
| Root cause | Labeling False and Misleading |
| Action | An Urgent Medical Device Corrective Action Notification letter, dated December 16, 2014, was sent to Owens & Minor, 1605 Worldwide Blvd., Hebron, KY 41048-8653, instructing them to immediately discontinue distribution and quarantine any products, use customer letter and Corrective Action Acknowledgement Form templates to communicate this corrective action to any of thier customers that have received product included within the scope of the corrective action, and to have their customers return a completed Corrective Action Acknowledgement Form outlining their remaining inventory of the affected |
| Quantity | 420 |
| Distribution | In the state of KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc., Aug 30, 2007 |