{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113548", "product_res_number": "Z-0171-2013", "event_date_initiated": "2012-07-11", "event_date_posted": "2012-11-01", "recall_status": "Terminated", "event_date_terminated": "2013-06-30", "res_event_number": "63347", "product_code": "BTM", "k_numbers": [ "K012842" ], "product_description": "Adult Resuscitator, Pro-5000 Series, Single Patient Use, \n\nThe Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.", "code_info": "Product List 071012, Product Code: PRO-5009P, Lot #102217.", "firm_fei_number": "1314417", "recalling_firm": "Ventlab Corporation", "address_1": "155 Boyce Dr", "city": "Mocksville", "state": "NC", "postal_code": "27028-4187", "additional_info_contact": "James A. Cochie\n336-753-5000", "reason_for_recall": "Possible volume leakage through the inlet valve during compressions of the resuscitator bag.", "root_cause_description": "Component design/selection", "action": "VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. 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