FDA-Device2024-09-04Class II
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
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: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2631-2024Don't want to check this manually?
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