FDA recall Z-1368-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. 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-1368-2025