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

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Montenegro, Netherlands, New Z Quantity: 48339 cases: 48148 cases US; 193 cases OUS 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

UPC codes

20650862115134, 20650862115141

Source

Official record: FDA (Device enforcement) ↗

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