MEDLINE INDUSTRIES, LP - Northfield product recalled over sterility concerns

Recall date

November 21, 2024

Source

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

Official notice title

MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF,…

Recall number

Z-0786-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

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

Why it was recalled

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

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

What was recalled

Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CUSTOM PACK A, REF DYNJ82735; 7) NSR-SMR, REF DYNJ903144C; 8) KIT FACIAL MINORPLASTICS MOSES, REF DYNJ905365A; 9) SEPTOPLASTY, REF DYNJ906474; 10) SEPTOPLASTY, REF DYNJ906474A; 11) FREE FLAP, REF DYNJ907802; 12) MINOR DIEP, REF DYNJ907863; 13) MAIN FLAP, REF DYNJ908264.