FDA recall Z-1370-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

Reason for recall

Potential breach in pouch packaging which could lead to loss of sterility.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-02-13
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1370-2025