Bard Peripheral Vascular Inc: 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 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.

Recall number

Z-1578-2020

Recalling firm

Bard Peripheral Vascular Inc

Product

1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 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.

Status

Terminated

Initiated

2019-10-01

Posted

not on file

Terminated

2022-02-18

Reason

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.

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 BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed to BDPI.CustomerSupportCenter@bd.com 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 BDPI.CustomerSupportCenter@bd.com

Quantity

225 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.

Lot, serial or model codes

0657525 Lot #: RECU1597 0607550 Lot #: RECR1508

510(k) numbers

["K022983"]

PMA numbers

not on file

Product code

LJT

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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