Z-1767-2018Class II

POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362

Name: Z-1767-2018 POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
Creator: Bard Peripheral Vascular Inc
Published: 2018-02-08
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2018-02-08 / Completed / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362 on 2018-02-08. FDA classified it as Class II and gives the reason as "The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1767-2018
Classification: Class II
Status: Completed
Initiated: 2018-02-08
Posted: 2018-05-09
Recalling firm: Bard Peripheral Vascular Inc
Product: POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions: "Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions. For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice. Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
Quantity in commerce: 4044 units
Distribution: Nationwide
Product codes and lots: Lot Number Unique Device Identifier (UDI) REAN0059 (01)00801741110757(17)170628(10)REAN0059 REAN1125 (01)00801741110757(17)170628(10)REAN1125 REAP0627 (01)00801741110757(17)170728(10)REAP0627 REBN2011 (01)00801741110757(17)180131(10)REBN2011 REBP0853 (01)00801741110757(17)180131(10)REBP0853 REBS1276 (01)00801741110757(17)181031(10)REBS1276 REBS2291 (01)00801741110757(17)181130(10)REBS2291 REBU1357 (01)00801741110757(17)181231(10)REBU1357 REBW1455 (01)00801741110757(17)190331(10)REBW1455 REBY0778 (01)00801741110757(17)190430(10)REBY0778

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1767-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1760-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1761-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1762-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1763-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1764-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1765-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1766-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1767-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1768-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1769-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1770-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1771-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1772-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09
Z-1773-2018	Class II	Completed	Voluntary: Firm initiated	2018-05-16	2018-05-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)