{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66964", "product_res_number": "Z-0535-2008", "event_date_initiated": "2007-08-21", "event_date_posted": "2007-12-22", "recall_status": "Terminated", "event_date_terminated": "2008-06-16", "res_event_number": "44734", "product_code": "BYE", "product_description": "Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark", "code_info": "Catalog Number: A137001000, Lot Numbers:  030046, and  040056.", "firm_fei_number": "1121788", "recalling_firm": "Ambu Incorporated", "address_1": "6740 Baymeadow Drive", "city": "Glen Burnie", "state": "MD", "postal_code": "21060-6412", "additional_info_contact": "Sanjay Parikh\n410-768-6464 Ext. 1136", "reason_for_recall": "Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.", "root_cause_description": "Process design", "action": "Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. \n\nAmbu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by \"Urgent Device Recall\" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.", "product_quantity": "197 total", "distribution_pattern": "Nationwide.", "openfda": { "k_number": [ "K901728", "K874479", "K770766", "K900164", "K900113", "K122610", "K902062", "K891540", "K090317", "K830395", "K760230", "K133210", "K981415", "K922178", "K953485", "K851396", "K893388", "K831503", "K834085", "K871693", "K781332", "K894779", "K160112", "K923618", "K882292", "K050918", "K932799", "K880161", "K001318", "K882219", "K962492", "K092029", "K923976", "K903764", "K843889", "K955047", "K963347", "K961867", "K883825", "K983920", "K802707", "K854458", "K861758", "K912240", "K904874", "K081266", "K873170", "K854822", "K875073", "K133957", "K843835", "K872202", "K112546", "K950397", "K912578", "K110713", "K090710", "K802943", "K895360", "K820404", "K894424", "K782152", "K802070", "K080256", "K013884", "K851194", "K831301", "K894690", "K860848", "K942246", "K800755", "K103833", "K881833", "K861104", "K982283", "K903125", "K070416", "K881614", "K953511", "K871523" ], "registration_number": [ "3010402691", "", "3018094310", "3044994756", "2245270", "3005587132", "2938401", "9610483", "2025816", "3020460367", "2028807", "3011503227", "1721686", "3023272766", "9611500", "1924066", "1223004", "3003924186", "9710567", "3009746061", "9710644", "1928237", "3000126629", "1220477", "9616567", "2936999", "8043316", "9612374", "1024404", "9710391", "3006783791", "3013557562", "8020889", "2518422", "8020785", "3011137372", "3011237704", "3005609751", "3009171251", "3009291251", "3006157842", "3025434453", "3017202422", "3002807314", "3005998497", "1832562", "3031369651", "3003697063", "1314417", "3002807561", "3006061749", "8044169", "2518436", "3003862188", "2022648", "3004365956", "3012494290", "3018783526", "8030673", "3006606984", "3030308442", "3015191173", "9681848", "9610849", "9610691", "9610861", "1526863", "3011185837", "3012542015", "8021995", "3004993040", "3011237770" ], "fei_number": [ "3010402691", "", "3018094310", "3044994756", "2245270", "3002807435", "3006363476", "3005587132", "2938401", "2025816", "3003924186", "3020460367", "1000120555", "3011503227", "1721686", "3023272766", "3003382061", "1924066", "3009746061", "1928237", "3003256355", "3003319165", "3000126629", "1220477", "3006759904", "3001104093", "1000283452", "2936999", "3004213967", "1024404", "3003949221", "3006783791", "3013557562", "1000374126", "2518422", "3011237704", "3005609751", "3002807391", "3002807836", "3009291251", "3006157842", "3025434453", "3017202422", "3003202124", "3002806674", "3002807314", "3005747797", "3005998497", "1832562", "3031369651", "3003697063", "3002806359", "1314417", "3002807561", "3006061749", "2518436", "3003862188", "2022648", "3002963732", "3004365956", "3012494290", "3018783526", "3030308442", "3006606984", "3000213164", "3015191173", "1526863", "3011185837", "3012542015", "3004993040", "3011237770" ], "device_name": "Attachment, Breathing, Positive End Expiratory Pressure", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5965", "device_class": "2" } } ] }