medical Class II Updated 2023-11-22

Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN,

Recalled Product

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Hazard / Issue

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020
View official government recall

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