Class 2 Device Recall PowerGlide ST Midline Catheter Maximal Barrier

• Date Initiated by Firm: March 17, 2020
• Create Date: May 09, 2020
• Recall Status: Terminated on October 21, 2020
• Recall Number: Z-1946-2020
• Recall Event ID: 85287
• 510(K)Number: K170158
• Product Classification: Midline catheter - Product Code PND
• Product: PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length; Catalog Number: ST018101D
• Code Information: Lot Number: REDW0476 20 Exp. Date: 20OCT30 UDI: (01)00801741139390
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: SAME as Above; 201-847-6800
• Manufacturer Reason for Recall: Iincorrectly packaged without the required lidocaine as labeled
• FDA Determined Cause: Packaging change control
• Action: BD issued Urgent Medical Device Recall letter issued on March 17, 2020 via Fed'x or email states reason for recall, health risk and action to take: 1.Examine your inventory of PowerGlide ST" Midline Catheter Maximal Barrier for product code ST018101D, Lot No. REDW0476. Inventory of this kit lot may be used by the clinician through alternate sourcing of lidocaine prior to initiating the procedure. Alternatively, any remaining inventory may be discarded. BD will provide you with a replacement for each kit discarded. 2.Share this recall notification with all users of the product within your facility to ensure they are also aware of this recall. 3.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse If you require further assistance, please contact: BD Contact Contact Information Customer/Technical Support Phone: 800-290-1689 Monday  Friday between 8:00 am to 5:00 pm MST in the United States
• Quantity in Commerce: 655 kits
• Distribution: AZ, CT, GA, IL, LA, MA, MI, MN, ND, NE, NY, OH, SD, TX),
• 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.