FDA recall Z-0122-2025

Product

MEDLINE OPEN HEART, REF DYNJ904261B

Reason for recall

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-08-28

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2025