Recall Z-0306-2022 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems Inc.
BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, n
| Date | Sep 8, 2021 |
| Status | Open, Classified |
| Reason | There is a breach in the product packaging that renders the product non-sterile. |
| Root cause | Packaging process control |
| Action | On September 30, 2021, the firm sent out a customer notification letter "Urgent Medical Device Recall" to their customers via Fed-Ex with the instruction due to the packaging breach, identified during the in house internal leak testing. This breach in the product packaging rendered the enclosed IV catheters non-sterile. Holes have been detected on the bottom tray of device unit packages. The notification stated to destroy the devices which are present in customers/distributors inventory. The recalling firm notified in a customer notification letter to fill and send the customer response form w |
| Quantity | 155,840 devices, 80 units in each box |
| Distribution | U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD, RI, MT, IN, PA, IL OK, OR, AK, CT, TX, ME, MO, FL, VA, LA, CO, UT O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183399 | BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems, Inc., Mar 20, 2019 |