FDA-Device2024-09-04Class II
Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
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: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2632-2024Don't want to check this manually?
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