FDA recall Z-1889-2025

Product

MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Reason for recall

Potential breach of sterile barrier packaging.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

Key facts

Status

Ongoing

Initiation date

2025-04-23

Report date

2025-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1889-2025