Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C…

Recall date
February 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1448-2025
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) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF, Pack Number DYNJ55345D; 7) C-SECTION PACK, Pack Number DYNJ04521J; 8) C-SECTION PACK, Pack Number DYNJ32632F; 9) C-SECTION PACK, Pack Number DYNJ65961B; 10) SMJ C-SECTION PACK-LF, Pack Number DYNJ38582J

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