FDA recall Z-2934-2018

Product

Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits

Reason for recall

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

Distribution

Nationwide distribution; worldwide distribution.

Key facts

Status

Terminated

Initiation date

2018-07-12

Report date

2018-09-05

Termination date

2020-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2934-2018