FDA-Device2024-09-04Class II
Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1,679,067 units in total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2633-2024Don't want to check this manually?
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