FDA recall Z-1938-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

Reason for recall

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.

Key facts

Status
Ongoing
Initiation date
2024-04-22
Report date
2024-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1938-2024