PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 4, 2018 Initiated: November 22, 2017 #Z-1271-2018

Product Description

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

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.

Details

Units Affected
24 Eaches
Distribution
CA, AR. AL
Location
Harleysville, PA

Frequently Asked Questions

What product was recalled?
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter. Recalled by Medical Components, Inc dba MedComp. Units affected: 24 Eaches.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1271-2018.