Recall Z-1710-2019 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson & Company
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
| Date | Mar 1, 2019 |
| Status | Terminated |
| Reason | Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | BD MDS (Medication Delivery Solutions) contacted via email and provided a hard copy letter via FedEx on March 1, 2019. The tetter describes the problem , action to take: Immediately review your inventory for the specific Catalog and lot number listed above.Destroy all product subject to the recall following your institutions process for destruction. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. . Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you ha |
| Quantity | 6,720 units |
| Distribution | US distribution to one distributor in VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc., Aug 29, 2016 |