—#183805

Product

Bard 3F SL PowerMidline Basic 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: P6153118

FDA product code: PND — Midline Catheter
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K162900
Affected lot / code info: Lot Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 on page 3 indicating: o the quantities destroyed OR o that your organisation does not have any impacted units left in inventory 4. Return the completed Customer Response Form to <> as soon as possible or no later than October 9th, 2020. Should you have any questions or require assistance relating to this Field Safety Notice, please contact your Local BD representative at <>

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Foreign: Italy, Spain, and UK

Timeline

Recall initiated: 2020-09-14
Terminated: 2021-11-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183805. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.