FDA recall Z-1527-2024

Product

Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490

Reason for recall

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Distribution

Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.

Key facts

Status

Ongoing

Initiation date

2024-03-01

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1527-2024