{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mechanicsville",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75649",
      "recalling_firm": "Owens & Minor Distribution, Inc.",
      "address_1": "9120 Lockwood Blvd",
      "address_2": "N/A",
      "postal_code": "23116-2015",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Nationwide Distribution.",
      "recall_number": "Z-0888-2017",
      "product_description": "Medi Choice Arm Slings    ASL 2103\tSmall 7.5 x 12.5 Inch\t1/EA, 24 ENCA  ASL 2104\tMedium 8 x 15 Inch\t1/EA, 24 ENCA  ASL 2105\tLarge 8.5 x 17.5 Inch\t1/EA, 24 ENCA  ASL 2106\tExtra-Large 9 x 20 Inch\t1/EA, 24 ENCA  ASL 2150\tUniversal 7 x 18 Inch\t1/EA, 24 ENCA    Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.",
      "product_quantity": "568 cases",
      "reason_for_recall": "Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc.    Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1\"1, 2016 reported surface contamination on the arm slings.  Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue.    Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions.  A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016.  The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots.    Owens & Minor has quarantined the affected product lots.  The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time.    Based  on the frequency  of the product  defect as well as evaluation of potential  adverse health event risk, Owens & Minor initiated  a voluntary  recall for the above stated affected  product  lots.",
      "recall_initiation_date": "20161031",
      "center_classification_date": "20161222",
      "termination_date": "20180109",
      "report_date": "20161228",
      "code_info": "Item#             Lot Number(s)    SL2103          1605BC02A, 1606BC02A    V'-SL2104           1605BC03A, 1606BC03A, 1607BC03A   V'-SL2105           1605BC04A, 1606BC04A, 1607BC04A   V'-SL2106           1605BC05A, 1606BC05A, 1607BC05A  ASL2150             1605BC06A, 1607BC06A"
    }
  ]
}