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FDA (Device enforcement)Recalled 2024-04-08class ii

MEDLINE INDUSTRIES, LP - Northfield: Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A

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 Lot/code info: MNS6950A, Lot Number 2018101150; MNS6950A, Lot Number 2019022550; MNS6950A, Lot Number 2019040350; BT515A, Lot Number 2020040990; BT515A, Lot Number 2021062990; BT515A, Lot Number 2022012090; BT515A, Lot Number 2022022890; BT515A, Lot Number 2022072990; BT515A, Lot Number 2022103190; BT515A, Lot Number 2023031790; BT515A, Lot Number 2023032890; BT515A, Lot Number 2023072590; BT515A, Lot Number 2024022990;

Source

Official record: FDA (Device enforcement)

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

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