{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "188142", "product_res_number": "Z-2162-2021", "event_date_initiated": "2021-04-21", "event_date_created": "2021-07-29", "recall_status": "Open, Classified", "res_event_number": "88213", "product_code": "GAA", "product_description": "Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: \n\nArticle no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; \nArticle no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm);\nArticle no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm);\nArticle no. KIM 20/15, Length 150 mm, diameter\t20 G (0.9 mm);\nArticle no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm);\nArticle no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); \nArticle no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); \nArticle no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm);\nArticle No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, \nArticle no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm);\nArticle no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm);\nArticle no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm);\nArticle no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm);\nArticle no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm);\nArticle no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm);\nArticle no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm);\nArticle no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm);\nArticle no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm);\nArticle no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)", "code_info": "Affected Lot Numbers:  KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820;  KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820;  KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520;  KIM 22/15: LOT: 1417, 2118,4319;  KIM 20/10: LOT: 4318;  KIM 20/15: LOT: 4318;  KIM 18/10: LOT: 0717, 4318;  KIM 18/10T: LOT: 0217;  KIM 18/15: LOT: 0717, 4318, 0920;  KIM 18/15T: LOT: 4318;  KIM 18/20: LOT: 4318;  KIM 13/04T: LOT: 0817, 4318;  KIM 13/09T: LOT: 0817, 4318;  KIM 13/14T: LOT: 0817, 4318;  KIM 15/04T: LOT: 2818;  KIM 15/09T: LOT: 2818;  KIM 15/14T: LOT: 2818;  KIM 16/04T: LOT: 2818, 4820;  KIM 16/09T: LOT: 2818, 4820, 5020;  KIM 16/14T: LOT: 2818, 4820;  KIM 14/20T: LOT: 2419;", "firm_fei_number": "3014408997", "recalling_firm": "INNOVATIVE TOMOGRAPHY PRODUCT GMBH", "address_1": "Universitatsstr. 136 136 universitatsstr.", "city": "Bochum", "country": "Germany", "reason_for_recall": "Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized", "root_cause_description": "Vendor change control", "action": "On April 20, 2021, Innovative Tomography Products GmbH issued a \"urgent Safety Information Product Recall\" notification to affected consignees via E-Mail. In addition to informing consignees about the recall products, the firm asked consignees mo to take the following actions: \n\n1. We request that you immediately check your stock of the products in question with the LOT numbers indicated. Please block the corresponding products and quarantine them.\n\n2. Please complete the attached response letter and return it to ITP via E-Mail to the following address:\n\nAddress: ITP GmbH\nRckrufunterlagen\nUniversittsstrae 136\n44799 Bochum\nGermany\n\nContact person:\nDominik Frmke\nTel.: +49 234 54621942\nFax: +49 234 54622444\nE-Mail: fraemke@innotom.com\n\n3. Upon receipt of the documents, we will contact you to retrieve and exchange the products.\nInformation sharing:\n\n4. Please inform all persons within your company belonging to the circle of users about this urgent safety", "distribution_pattern": "US Nationwide distribution in the state of CA.", "openfda": { "k_number": [ "K863326", "K962425", "K800407", "K914608", "K800410", "K790472", "K820070", "K821697", "K831392", "K894872", "K102274", "K873124", "K930158", "K790060", "K915417", "K894875", "K790079", "K961959", "K925621", "K910036", "K801754", "K800409", "K821017", "K760022", "K912074", "K830378", "K771760", "K894873", "K852817", "K842230", "K852897", "K801457", "K880377", "K882105", "K994151", "K843925", "K922614", "K854579", "K800417", "K851957", "K223625", "K895012", "K901438", "K940025", "K760775", "K854238", "K810248", "K781371", "K790142", "K945109", "K852427", "K800413", "K800415", "K894874", "K801753", "K781264", "K811771", "K011586", "K925416", "K853980", "K821348", "K883014", "K813448", "K851953", "K842106", "K813460", "K910117", "K771759", "K800421", "K913992", "K810076", "K870896", 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"3003040625", "3009217531", "3017538679", "3013466775", "3012037425", "3015060216" ], "device_name": "Needle, Aspiration And Injection, Disposable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }