{
  "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": "191674",
      "product_res_number": "Z-0708-2022",
      "event_date_initiated": "2022-01-17",
      "event_date_created": "2022-03-01",
      "recall_status": "Open, Classified",
      "res_event_number": "89463",
      "product_code": "LZU",
      "k_numbers": [
        "K021831"
      ],
      "product_description": "OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE\nDry eye treatment",
      "code_info": "HP3\t010819-3104\nHP3\t011321-3373\nHP3\t031519-3128\nHP3\t032521-3426\nHP3\t051419-3157\nHP3\t073118-3044\nHP3\t090921-3516\nHP3\t102618-3060\nHP5\t011221-3374\t\nHP5\t012519-3088\nHP5\t032019-3123\nHP5\t032621-3425\nHP5\t051519-3158\nHP5\t062521-3489\nHP5\t070819-3186\nHP5\t072221-3501\nHP5\t083018-3036\nHP5\t102918-3061\nHP5\t122120-3368\nHP7\t030821-3404\nHP7\t032119-3124\nHP7\t092019-3135\nHP7\t103018-3062",
      "firm_fei_number": "2024818",
      "recalling_firm": "Lacrimedics Inc",
      "address_1": "2620 Williamson Pl Ste 113 2620 Williamson Pl",
      "address_2": "Ste 113",
      "city": "Dupont",
      "state": "WA",
      "postal_code": "98327-9518",
      "additional_info_contact": "253-964-0360",
      "reason_for_recall": "The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.",
      "root_cause_description": "Packaging process control",
      "action": "Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs customer \n letters, dated January 17, 2022 and Urgent : Medical Device Recall, Collagen Plugs and Opaque Herrick Lacrimal Plugs distributor letters, dated January 17, 2022 sent starting 1/24/2022 (through 1/28/2022 US and 2/4/2022 (OUS)) via USPS certified letter with return receipt;  Distributors and customers are instructed in letter to discontinue distribution and/or use and return remaining product for replacement\n\"\tContact their customers regarding the product(s) and request the return of remaining product for replacement. (distributors)\n\"\tAcknowledge recall by returning the Recall Response Form to Tanya Traband:  \nTTraband@lacrimedics.com or\nFAX: (253) 964-2699 or Lacrimedics, Inc. \n2620 Williamson Place, Suite 113 DuPont, WA 98327  \nOther information:  \nContact Tanya Traband, Manager Client Relationships, at TTraband@lacrimedics.com or +1.800.367.8327 Ex. 200 Monday through Friday 8:30 a.m. to 4:00 p.m. PST.  \n\"\tDirect customers are instructed to return product for replacement; prepaid UPS labels are sent with the letter for this purpose",
      "product_quantity": "5767 units",
      "distribution_pattern": "Nationwide and Worldwide Distribution to following countries - AR. BE, BO, BR, CH, CN, CO, CZ, DE, EC, ES, FI, GE, IN, IL, MY, MX, NZ, PE, RO, SG, SA, TR, TW, TZ, UK",
      "openfda": {
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          "K911108",
          "K001768",
          "K053333",
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          "K980437",
          "K241229"
        ],
        "registration_number": [
          "1211998",
          "1045379",
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          "2011171",
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          "1000136478",
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        ],
        "device_name": "Plug, Punctum",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}