Recall Z-0384-2019 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson & Company
BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD
| Date | Aug 23, 2018 |
| Status | Terminated |
| Reason | One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 8/23/18 were sent to customers. The letters instruct customers to perform the following actions: 1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above and destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the imp |
| Quantity | 133,230 units |
| Distribution | Worldwide Distribution -US Nationwide in the states of: CA, CO, FL, GA, IL, LA, MI, ND, NE, NY, OH, PA, RI, SC, VA, WA and WV. The products were distributed to the following foreign countries: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032843 | NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc., Feb 27, 2004 |