Z-1576-2020Class II

BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680...

Name: Z-1576-2020 BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680...
Creator: Bard Peripheral Vascular Inc
Published: 2019-10-01
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-10-01 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard... on 2019-10-01. FDA classified it as Class II and gives the reason as "Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1576-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Posted: 2020-03-26
Terminated: 2022-02-18
Recalling firm: Bard Peripheral Vascular Inc
Product: BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. 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: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
FDA root cause: Component change control
Action: On October 1, 2019, Bard sent a "Urgent Medical Device REcall Notification" letter to all customers via FedEx. The recall notification informed customer about the reason for the recall. In addition, to informing customers about the recall, the letter asked that customers take the following actions: 1. Our records show that your facility has purchased product codes affected by this voluntary recall. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Email the completed Recall and Effectiveness Check Form to [email protected] or fax it to BPV at 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed to [email protected] or faxed to BPV at 1-800-994-6772 and all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacement product for your returned product. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at [email protected]
Quantity in commerce: 2493 Catheters
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Product codes and lots: Lot # RECU2404, RECU1067, RECR1439, RECT0078

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1576-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1570-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1571-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1572-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1573-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1574-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1575-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1576-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1577-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1578-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1579-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code LJT

K873213Class IIHickman Plastic Subcutaneous PortC.R. Bard, Inc. / cleared 1987-10-27

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)