Z-0582-2020Class II

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

Name: Z-0582-2020 PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Creator: Bard Peripheral Vascular Inc
Published: 2019-02-14
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-02-14 / Open, Classified / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter on 2019-02-14. FDA classified it as Class II and gives the reason as "Complaints received that products packaged with the incorrect introducer sheath size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0582-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-14
Posted: 2019-11-27
Recalling firm: Bard Peripheral Vascular Inc
Product: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Complaints received that products packaged with the incorrect introducer sheath size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/14/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via FedEx informing them the firm has identified one product code/lot number (RECS2407) may be at risk of incorrectly containing a 6.5Fr introducer sheath instead of an 8Fr introducer sheath. Customer are instructed to: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within their 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, and to immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to the Recalling Firm. 3. Remove any identified product from their shelves. 4. If the customers have used the affected product, to 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 customer inventory: 5. Fill out the Recall and Effectiveness Check Form and to be sure to state the quantities and lot numbers of each recalled product that is intended to be returned. It is extremely important that the Recalling Firm receive this information. 6. Please call Customer Support Center at 1-800-321-4254 Option #5 (M-F 6am to 3pm MST) or email at [email protected]. Once all information has been verified, Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. The Recalling Firm will issue a replacement product for its customer's returned product. 7. Email the completed Recall and Effectiveness Check Form to [email protected] or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing label will be enclosed for the custo
Quantity in commerce: 900 units
Distribution: US - Nationwide OUS - None
Product codes and lots: Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0582-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-27

Product code LJT

K063377Class IIPowerport Polymetric Port with 8 Fr S/l Chronoflex CatheterC.R. Bard, Inc. / cleared 2007-01-25

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)