FDA recall Z-1271-2018

Product

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.

Distribution

CA, AR. AL

Key facts

Status

Terminated

Initiation date

2017-11-22

Report date

2018-04-04

Termination date

2018-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2018