FDA recall Z-1112-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827

Reason for recall

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-12-07
Report date: 2023-02-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2023