FDA recall Z-0122-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592

Reason for recall

Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

Distribution

US Nationwide distribution in the state of California.

Key facts

Status
Ongoing
Initiation date
2022-09-09
Report date
2022-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2023