4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
FDA device recall Z-0127-2016 · posted 2015-10-15 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 31590
- Distribution
- Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.
- Date initiated
- 2015-09-18
- Date posted
- 2015-10-15
- Date terminated
- 2020-06-25
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRESSURE INJECTABLE PICC (K073451) | Arrow International, Inc. | 2008-01-15 |
| ARROW PRESSURE INJECTABLE PICC (K061289) | Arrow International, Inc. | 2006-08-24 |