FDA recall Z-1136-2025

Cardinal Health 200, LLC · Class II · device

Product

Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLX 10) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLY 11) OCULAR PLASTIC PACK, Catalog Number:SEY35OPBLZ

Reason for recall

Potential for 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: 2025-02-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1136-2025