Recall Z-0295-2021 ยท PND Midline Catheter
Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
| Date | Sep 14, 2020 |
| Status | Terminated |
| Reason | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit. |
| Root cause | Nonconforming Material/Component |
| Action | Becton Dickinson (BD) issued notification letter to FSN Europe on 9/14/20 to customer stating reason for recall, health risk and action to take specific to the country: Advice on actions to be taken by the Distributor: 1. Inspect your inventory, locate and quarantine any units of the impacted devices listed in Table 1. 2. If you have further distributed the product, please identify those facilities, notify them at once of this product removal and have them return the affected product to your facility. 3. Destroy any unused units of the affected product and complete the customer response form |
| Quantity | 72 units |
| Distribution | Foreign: Italy, Spain, and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162900 | PowerMidline Catheter C.R. Bard, Inc., Dec 14, 2016 |