{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "25087",
      "product_res_number": "Z-0420-03",
      "event_date_initiated": "2002-11-15",
      "event_date_posted": "2003-01-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-04-14",
      "res_event_number": "25054",
      "product_code": "GCB--",
      "product_description": "Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA",
      "code_info": "L1J035X, L1J088, L1K042, L1K058, L1K070, L1L057X, L1N018, L1N031, L1N039X, L1N094, L1P017, L1P045, L1S015, L2A012, L2A021, L2A048, L2A075, L2B039, L2B047 ,L2B073, L2C012, L2C038, L2C083, L2D041, L2D067, L2E036  The recall was expanded on 4/8/04 to include the following additional lots: L1J072, L2D102X, L2H001, L2H007, L2J004, L2J021, L2J088, L2K001, L2K021, L2L026, L2L037, L2N022, L2N085, L2P113, L2S123X, L2S128, L2S166, L2S185, L3A105, L3A218X, L3A224.",
      "firm_fei_number": "3001236905",
      "recalling_firm": "Cardinal Health",
      "address_1": "1430 Waukegan Rd ATTN V. MUELLER QA",
      "city": "McGaw Park",
      "state": "IL",
      "postal_code": "60085",
      "additional_info_contact": "Quality Systems - Professional Services\n800-292-9332",
      "reason_for_recall": "Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.",
      "root_cause_description": "Other",
      "action": "Recall letters dated 11/15/02 were sent via 2-day FedEx to the direct accounts.  The accounts were informed of the potential for breakage of the catheters during use, requested  to inspect their inventories for the affected lot numbers, and segregate any found for return to Allegiance for replacement.  Distributors were requested to sub-recall the product from their accounts.\n\nThe recall was extended to include the 21 additional lots by letter dated 4/8/04.  The letters were sent via Airborne Express, 1-Day, on 4/8/04.  The instructions were the same as the 11/15/02 letter, except that Allegiance has changed their name to Cardinal Health.",
      "product_quantity": "232,228 trays",
      "distribution_pattern": "Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia",
      "openfda": {}
    }
  ]
}