—#186692

Product

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - 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.

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090512
Affected lot / code info: Code: REEV2356, REEX1383, REEX3996

Why it was recalled

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-03-25
Terminated: 2023-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186692. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.