Atrium Medical Corporation: Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100

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: 31270 cases: 29942 cases US; 1328 cases OUS Lot/code info: 1)2002-000 DRAIN, OCEAN SINGLE W/AC,S 20650862100017 (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN, OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN, OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN, OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN, OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN, OCEAN BRU W/AC,S 20650862103018 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

20650862100017, 20650862100345, 20650862100093, 20650862100109, 20650862100215, 20650862101021, 20650862103018

Source

Official record: FDA (Device enforcement) ↗

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