MEDLINE INDUSTRIES, LP - Northfield: 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 N

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 1,679,067 units in total Lot/code info: ECVC8105, Lot Number 2023052690; ECVC8105, Lot Number 2023100490; ECVC8045, Lot Number 2023110990

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.