{ "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": "104739", "product_res_number": "Z-0262-2012", "event_date_initiated": "2011-10-12", "event_date_posted": "2011-11-21", "recall_status": "Terminated", "event_date_terminated": "2012-02-23", "res_event_number": "60205", "product_code": "KOY", "product_description": "PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . \n\nHook-up kits that contain the affected alcohol prep pads are as follows:\n\nAria, Kit Part number 23189-010, Kit, Basic hookup, AA;\nCardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall;\nAria, Kit Part number 23189-106, Kit, Aria Hookup;\nAria, Kit Part number 23189-110, Kit, Aria Hookup;\nFlashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup;\nAria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode;\nLifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual;\nAria, Kit Part number 23189-115, Kit, Basic Hookup, AAA;\nLifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard;\n483, Kit Part number 23189-117, Kit, Holter Hookup 483;\nAria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode;\nAria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC;\nEVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch;\nEVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch;\nEVO, Kit Part number SK10456, Sample Kit, Disposables.\n\nA surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.", "code_info": "B339 is listed on the PDI Alcohol Prep Pads.  Hook-up kits that contain the affected alcohol prep pads are as follows:  Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.", "firm_fei_number": "3002807992", "recalling_firm": "Del Mar Reynolds Medical, Ltd.", "address_1": "1-2 Harforde Ct., Foxholes 1-2 Harforde Ct. Foxholes Business Park", "city": "Hertford", "country": "United Kingdom", "reason_for_recall": "The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI).", "root_cause_description": "Material/Component Contamination", "action": "SpaceLabs Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the affected product and dispose of them per their hospital or clinic protocol. \n\nFor questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2\nfor Technical Support.", "product_quantity": "25,000 pieces of PDI alcohol prep pads-15 different Spacelabs hook-up kits", "distribution_pattern": "Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait", "openfda": { "registration_number": [ "3035479692", "3017417635", "3016603542", "3011534533", "3007517215", "3021769057", "1214815", "3016450032", "3008808082", "8030128", "3006552462", "3009308084", "3009486864", "3038637162", "3008973760", "3042158718" ], "fei_number": [ "3035479692", "3017417635", "3016603542", "3011534533", "3007517215", "3021769057", "1214815", "3016450032", "3008808082", "3006552462", "3009308084", "3009486864", "3038637162", "3008973760", "3042158718", "3006118668" ], "device_name": "Degreaser, Skin, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4730", "device_class": "1" } } ] }