Recall Z-1221-2017 ยท GBZ Catheter, Cholangiography
Atrium Medical Corporation
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
| Date | Jan 20, 2017 |
| Status | Terminated |
| Reason | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) |
| Root cause | Labeling design |
| Action | Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST). |
| Quantity | 660 cases (10/case) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831931 | ATRIUM THORACIC CATHETER Atrium Medical Corp., Oct 4, 1983 |