Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK recalled over sterility concerns

Recall date

November 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR…

Recall number

Z-1136-2025

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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