Home / Recalls / Atrium Medical Corporation / Z-0316-2024

Z-0316-2024 Class II Ongoing

Recalled by Atrium Medical Corporation — Merrimack, NH

FDA device recall Z-0316-2024 was initiated by Atrium Medical Corporation on September 18, 2023 and is designated Class II. 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 si… The recall status is ongoing. Affected quantity: 31270 cases: 29942 cases US; 1328 cases OUS.

Recall Details

Product Type: Devices
Report Date: November 22, 2023
Initiation Date: September 18, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31270 cases: 29942 cases US; 1328 cases OUS

Product Description

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 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S

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 Pattern

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 Zealand, Norway, Pakistan, Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.

Code Information

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

Other recalls by Atrium Medical Corporation

Z-0024-2025 Class II — iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 (September 9, 2024)
Z-1979-2024 Class II — ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-2015-2024 Class II — FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-1966-2024 Class II — ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-1954-2024 Class II — ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft (May 3, 2024)
Z-1968-2024 Class II — ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-2003-2024 Class II — FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-1970-2024 Class II — ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-2010-2024 Class II — FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft (May 3, 2024)
Z-2012-2024 Class II — FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft (May 3, 2024)