FDA recall Z-0909-2025

Cardinal Health 200, LLC · Class II · device

Product

Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMP:;

Reason for recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Key facts

Status: Ongoing
Initiation date: 2024-11-08
Report date: 2025-01-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2025