{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Merrimack",
      "state": "NH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93149",
      "recalling_firm": "Atrium Medical Corporation",
      "address_1": "40 Continental Blvd",
      "address_2": "N/A",
      "postal_code": "03054-4332",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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.",
      "recall_number": "Z-0316-2024",
      "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",
      "product_quantity": "31270 cases: 29942 cases US; 1328 cases OUS",
      "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",
      "recall_initiation_date": "20230918",
      "center_classification_date": "20231116",
      "report_date": "20231122",
      "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"
    }
  ]
}