{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176198", "product_res_number": "Z-0234-2020", "event_date_initiated": "2019-08-30", "event_date_created": "2019-10-29", "recall_status": "Open, Classified", "res_event_number": "83714", "product_code": "BSP", "k_numbers": [ "K911260" ], "product_description": "SPROTTE Lumbar with Introducer, labeled as the following: \n\n1. Sprotte 22G x 90mm w/ introducer and wings (25/box); \n\n2. Sprotte 22G x 120mm w/ introducer and wings (25/box); \n\n3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); \n\n4. Sprotte 22G x 103mm w/ introducer and wings (25/box); \n\n5. Sprotte 21G x 90mm w/ introducer and wings (25/box); \n\n6. Sprotte 21G x 103mm w/ introducer and wings (25/box); \n\n7. Sprotte 20G x 103mm w/ introducer and wings (25/box); \n\n8. Sprotte 20G x 90mm w/ introducer and wings (25/box)\n\nProduct Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.", "code_info": "Lot Numbers 1240 through 1313. Item numbers:   1. 321151-30C;   2. 331151-30C;   3. 321151-31C;   4. 341151-30C;   5. 321151-31A;   6. 341151-31A;   7. 341151-31B;   8. 331151-31B", "firm_fei_number": "3002807847", "recalling_firm": "Pajunk GmbH", "address_1": "Karl-hall-str. 1 1 karl-hall-str.", "city": "Geisingen", "country": "Germany", "reason_for_recall": "Problem with packaging sealing process which affects sterility.", "root_cause_description": "Process control", "action": "Pajunk GmbH Medizintechnologie notified distributor and end customers on about 08/30/2019, via \"Urgent Product Recall Notice\" letters. Instructions included to immediately identify any affected products in inventory and quarantine them, cease use of affected products, and complete and return the Attachment B indicating receipt of the notice. \n\nAdditionally end customers and distributors were instructed to provide the recall notice to all responsible personnel within the organization or if products were further distributed. \n\nQuestions or concerns can be directed to Laura Roberts, Manager of Office of Operations and Client Relations, email Laura.roberts@pejunk-usa.com, phone (470) 448-4075.", "product_quantity": "40,475 devices", "distribution_pattern": "Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, RI, SC, TN, TX, WI, WY. \n\nCountries of Germany, Ellada / Greece, Canada, Italy, Lietuva / Lithuania/ Litauen, Australia, Luxembourg, Austria, Nederland / Netherlands, Belgium, Polska / Poland, Switzerland, Sverige / Sweden, Czech Republic, Slovenija / Slovenia, Danmark / Denmark, Kroatien/ Croatia, Espa¿a / Spain, Aserbeidschan/ Azerbaidzan, Suomi / Finland, Brunei, France, Russland/ Russia, Great Britain, Oman, Israel.", "openfda": { "device_name": "Needle, Conduction, Anesthetic (W/Wo Introducer)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5150", "device_class": "2", "k_number": [ "K163216", "K073222", "K072005", "K203668", "K070354", "K083909", "K951411", "K111374", "K170112", "K950820", "K081864", "K193131", "K110194", "K823692", "K043467", "K000495", "K163292", "K980536", "K023218", "K813165", "K080603", "K920305", "K843313", "K894880", "K951312", "K002405", "K183316", "K100241", "K163435", "K952275", "K173155", "K945965", "K050499", "K894881", "K935255", "K171968", "K895453", "K160295", "K250774", "K172410", "K212982", "K113207", "K011122", "K093209", "K160297", "K854149", "K053318", "K061210", "K853478", "K943649", "K911260", "K170435", "K241953", 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