FDA recall Z-2520-2025

O&M HALYARD INC · Class II · device

Product

Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

Reason for recall

Surgical drape packs may have open seals, which may compromise the sterility of the product.

Distribution

Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.

Key facts

Status
Ongoing
Initiation date
2025-07-17
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2520-2025