FDA recall Z-1129-2023

Product

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Reason for recall

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Distribution

US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

Key facts

Status

Ongoing

Initiation date

2022-12-16

Report date

2023-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1129-2023