Recall Z-1119-2019 ยท DQY Catheter, Percutaneous
Arrow International Inc
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
| Date | Jan 10, 2019 |
| Status | Terminated |
| Reason | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct |
| Root cause | Error in labeling |
| Action | Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form |
| Quantity | 45 eaches total (US) |
| Distribution | FL, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |