Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DY…

Recall date
February 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1452-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

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 procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 6) ARTHROSCOPY TRAY, Pack Number DYNJ46435A; 7) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50120D

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