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U.S. Department of Health and Human Services

Class 2 Device Recall PowerMidline Catheter

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  Class 2 Device Recall PowerMidline Catheter see related information
Date Initiated by Firm September 14, 2020
Create Date October 23, 2020
Recall Status1 Terminated 3 on November 09, 2021
Recall Number Z-0295-2021
Recall Event ID 86477
510(K)Number K162900  
Product Classification Midline catheter - Product Code PND
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
Code Information Lot Number:  REEQ3598 Feb-2022 and REER0518 Mar-2022 UDI: 00801741141065
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
201-847-6800
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PND and Original Applicant = C.R. Bard, Inc.
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