Recall Z-0127-2016 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
| Date | Oct 15, 2015 (initiated Sep 18, 2015) |
| Status | Terminated |
| Reason | Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections. |
| Root cause | Under Investigation by firm |
| Action | An urgent medical device notification, dated September 22, 2015, was sent to direct accounts to alert them about the issue, the potential risks, and provide instructions for returning the completed response form and affected devices. |
| Quantity | 31590 |
| Distribution | Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand. |
| FDA record | Open on fda.gov |