Z-0295-2021Class II

Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for...

Name: Z-0295-2021 Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for...
Creator: Becton Dickinson & Company
Published: 2020-09-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-09-14 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and... on 2020-09-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0295-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-14
Posted: 2020-10-23
Terminated: 2021-11-09
Recalling firm: Becton Dickinson & Co
Product: 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
Product code: PND Midline Catheter
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 72 units
Distribution: Foreign: Italy, Spain, and UK
Product codes and lots: Lot Number: REEQ3598 Feb-2022 and REER0518 Mar-2022 UDI: 00801741141065

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0294-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23
Z-0295-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code PND

K162900Class IIPowerMidline CatheterC.R. Bard, Inc. / cleared 2016-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)