{ "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": "43191", "product_res_number": "Z-0406-06", "event_date_initiated": "2005-11-23", "event_date_posted": "2006-01-18", "recall_status": "Terminated", "event_date_terminated": "2006-02-01", "res_event_number": "34145", "product_code": "KZJ", "product_description": "BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25", "code_info": "BBL¿ GasPak¿ Pouch System  Batch\tExpiration  \tDate 5214643\t08/31/06 5214642\t08/31/06 5214640\t08/31/06 5194865\t08/31/06 5194863\t08/31/06 5189360\t07/31/06 5189359\t07/31/06 5189358\t07/31/06 5189357\t07/31/05 5189356\t07/31/06 5189355\t07/31/06 5189353\t07/31/06 5182704\t07/31/06 5182703\t07/31/06 5182702\t07/31/06 5182701\t07/31/06 5165500\t06/30/06 5165499\t06/30/06 5165496\t06/30/06 5165494\t06/30/06 5165491\t06/30/06 5158860\t06/30/06 5154612\t06/30/06 5154610\t06/30/06 5152966\t06/30/06 5152958\t06/30/06 5146724\t06/30/06 5126942\t05/31/06 5119623\t05/31/06 5119622\t05/31/06 5119621\t05/31/06 5119620\t05/31/06 5119619\t05/31/06 4345515\t12/31/06 5097847\t04/30/06 5097845\t04/30/06 5097841\t04/30/06 5097838\t04/30/06 5097837\t04/30/06 5074202\t03/31/06 5074200\t03/31/06 5074198\t03/31/06 5069662\t03/31/06 5069660\t03/31/06 5069659\t03/31/06 5061870\t03/31/06 5061866\t03/31/06 5056474\t03/31/06 5056472\t03/31/06 5056471\t03/31/06 5052074\t01/31/06 5052071\t01/31/06 5052070\t01/31/06 5048914\t01/31/06 5040337\t01/31/06 5040336\t01/31/06 5035915\t01/31/06 5035914\t01/31/06 5032185\t01/31/06 5032184\t01/31/06 5031047\t01/31/06 5031045\t01/31/06 5028254\t01/31/06 5021661\t01/31/06 5019413\t01/31/06 5019411\t01/31/06 5013255\t01/31/06 5013253\t01/31/06 5010278\t01/31/06 5010276\t01/31/06 5010274\t01/31/06 4365412\t01/31/06 4355778\t12/31/05 4355774\t12/31/05 4355771\t12/31/05 4352493\t12/31/05 4345533\t12/31/05 4345531\t12/31/05 4345521\t12/31/05 4345518\t12/31/05 4345515\t12/31/05 4343926\t12/31/05 4343923\t12/31/05 4343922\t12/31/05 4341958\t11/30/05 4338027\t11/30/05 4338025\t11/30/05 4338023\t11/30/05 4324272\t11/30/05 4324271\t11/30/05 4324269\t11/30/05 4324267\t11/30/05 4316041\t11/30/05 4316036\t11/30/05 4316035\t11/30/05 4316033\t11/30/05 4316030\t11/30/05 4316029\t11/30/05 4315197\t11/30/05 4315194\t11/30/05 4315192\t11/30/05 4303939\t11/30/05 4303937\t11/30/05 4303933\t11/30/05 4303932\t11/30/05 ********************************************************************************************************* BBL¿ GasPak¿ CampyPouch¿ System\t Batch\tExpiration Date  5164299\t8/31/2006 5158868\t6/30/2006 5158867\t6/30/2006 5158866\t6/30/2006 5129239\t5/31/2006 5126951\t5/31/2006 5126949\t5/31/2006 5126947\t5/31/2006 5104863\t4/30/2006 5104862\t4/30/2006 5104859\t4/30/2006 5063685\t3/31/2006 5063687\t3/31/2006 5063684\t3/31/2006 5055069\t3/31/2006 5048900\t2/28/2006 5046481\t2/28/2006 5046480\t2/28/2006 5042726\t2/28/2006 5042721\t2/28/2006 5024692\t1/31/2006 5024129\t1/31/2006 5024120\t1/31/2006 5024692\t1/31/2006 4335944\t12/31/2005 4335943\t12/31/2005 4335938\t12/31/2005 4335940\t12/31/2005 4335932\t12/31/2005 4335935\t12/31/2005 4303906\t11/30/2005 4303857\t11/30/2005", "firm_fei_number": "1119779", "recalling_firm": "Becton Dickinson & Co.", "address_1": "7 Loveton Cir", "city": "Sparks", "state": "MD", "postal_code": "21152-9212", "additional_info_contact": "Becton Dickinson Technical Services\n800-638-8663", "reason_for_recall": "Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.", "root_cause_description": "Other", "action": "The recalling firm notified distributors by letter on 11/23/05 and advised that identified lots of the devices contain a component contaminated with the bacteria Ralstonia picketti. Distributors were instructed to discontinue distribution and discard. Distributors were requested to provide consignee lists to the recalling firm for direct notification to consignees. Distributors were notified that the recalled products have been discontinued. Customers are asked to discard Liquid Activating Reagent Packets and return the response form enclosed for replacement of the packets or alternatively use existing packets by adding user supplied de-ionized or sterile water into the reagent channel of the pouch.", "product_quantity": "61647 boxes of 25/box", "distribution_pattern": "Product was distributed to direct accounts and distributors nationwide and to international affiliated distributors.", "openfda": { "k_number": [ "K820010", "K800796", "K862123", "K811957", "K872782", "K853534", "K802494", "K820308", "K881502", "K800539", "K871238", "K841117", "K845008", "K871709", "K875362", "K800899", "K844571", "K832229" ], "device_name": "Device, Gas Generating", "medical_specialty_description": "Microbiology", "regulation_number": "866.2580", "device_class": "1", "registration_number": [ "1217058", "3002821232", "3043138885", "3043088937", "3027645317", "3013823481", "2647876", "3023443877", "1119779", "3017207289", "3031700059", "9681165", "2242239", "1314344", "3013160357", "2518435", "8010096", "3042989733" ], "fei_number": [ "1217058", "3002821232", "3043138885", "3043088937", "1000175159", "3027645317", "3013823481", "3006224287", "2647876", "3023443877", "1119779", "3017207289", "3031700059", "1000087290", "2242239", "3013160357", "2518435", "3042989733" ] } } ] }