FDA recall Z-0963-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A

Reason for recall

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-12-21
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2024