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
FDA device recall Z-1005-2015 · posted 2015-01-22 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- the Instructions for Use (IFU) were inadvertently removed from the kit.
- Action taken
- 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 product codes and lot numbers for which replacement IFUs is needed.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 420
- Distribution
- In the state of KY
- Date initiated
- 2014-12-16
- Date posted
- 2015-01-22
- Date terminated
- 2015-08-10
- 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 |
|---|---|---|
| ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER (K071538) | Arrow International, Inc. | 2007-08-30 |