FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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
- Recall number
- Z-0294-2021
- Recalling firm
- Becton Dickinson & Company
- 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
- Status
- Terminated
- Initiated
- 2020-09-14
- Posted
- not on file
- Terminated
- 2021-11-09
- 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 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 <>
- Quantity
- 45 units OUS only
- Distribution
- Foreign: Italy, Spain, and UK
- Lot, serial or model codes
- Lot Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027
- 510(k) numbers
- ["K162900"]
- PMA numbers
- not on file
- Product code
- PND
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28