Class 2 Device Recall PowerPort duo M.R.I. Implantable Port

• Date Initiated by Firm: March 25, 2021
• Create Date: May 10, 2021
• Recall Status: Terminated on April 10, 2023
• Recall Number: Z-1550-2021
• Recall Event ID: 87656
• 510(K)Number: K090512
• Product Classification: Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
• Product: PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
• Code Information: Code: REEU3063, REEV0989, REEV2633, REEX1380, REEZ1991
• Recalling Firm/ Manufacturer: Bard Peripheral Vascular Inc; 1625 W 3rd St Bldg 1; Tempe AZ 85281-2438
• For Additional Information Contact: North America Regional Complaint Center; 844-823-5433
• Manufacturer Reason for Recall: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
• FDA Determined Cause: Process control
• Action: On March 25,2021 Bard Peripheral Vascular distributed an "Urgent: Medical Device Recall notification to affected customers via FedEx and E-Mail. In addition to informing consignees about the recall, the firm ask customer to take the following actions: 1. Please check all inventory locations within your institution for the specific catalog and lot numbers of the PowerPort duo M.R.I. Implantable Ports listed above and immediately destroy all affected product remaining in your possession. 2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Recall. 3. If you purchased this product from a distributor, contact your distributor for further instructions. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the recall notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable replacement orders. 5. 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 Event Reporting program: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 6. For customer support contact: 1-844-823-5433, Say "Recall" when prompted, M-F 8:00AM - 5:00 PM CT Actions Taken by BD: 1. BD will process replacement orders for all customers affected by the recall following receipt of the completed Customer Response Form. 2. Based on inventory levels there may be a delay of 6 weeks or more in the fulfillment of replacement orders. BD understands that supply interruptions can impact our customers ability to provide the best care for their patients and takes this matter very seriously, as such we fulfill orders as quickly as possible. 3. BD has implemen
• Quantity in Commerce: 2,194 units
• Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV.
• 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 = LJT and Original Applicant = C.R. BARD, INC.