FDA recall Z-0534-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.

Reason for recall

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Distribution

US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

Key facts

Status
Ongoing
Initiation date
2024-10-15
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0534-2025