Z-1271-2018Class II

8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter

Name: Z-1271-2018 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
Creator: Medical Components, Inc dba MedComp
Published: 2017-11-22
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2017-11-22 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter on 2017-11-22. FDA classified it as Class II and gives the reason as "The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1271-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-22
Posted: 2018-03-29
Terminated: 2018-07-11
Recalling firm: Medical Components, Inc.
Product: 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/
Quantity in commerce: 24 Eaches
Distribution: CA, AR. AL
Product codes and lots: Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1271-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1271-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-29

Product code LJT

K132177Class IIMedcomp Gen III Power Injectable PortMedcomp ( Medical Components) / cleared 2013-12-12

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)