Z-1552-2021Class II

PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous...

Name: Z-1552-2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous...
Creator: Bard Peripheral Vascular Inc
Published: 2021-03-25
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2021-03-25 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product... on 2021-03-25. FDA classified it as Class II and gives the reason as "Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements". 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-1552-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-25
Posted: 2021-05-10
Terminated: 2023-04-10
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Root cause tag: manufacturing process
FDA root 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: 287 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.
Product codes and lots: Code: REEV2356, REEX1383, REEX3996

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1552-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1550-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10
Z-1551-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10
Z-1552-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10

Product code LJT

K090512Class IIPowerport Duo m.r.i. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane CatheterC.R. Bard, Inc. / cleared 2009-03-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)