{ "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": "159745", "product_res_number": "Z-0256-2018", "event_date_initiated": "2017-06-27", "event_date_created": "2018-06-21", "recall_status": "Terminated", "event_date_terminated": "2019-07-16", "res_event_number": "78546", "product_code": "DTL", "k_numbers": [ "K820297" ], "product_description": "TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J", "code_info": "SAFETY ALERT Lot Codes:  (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10    (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01   LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017", "firm_fei_number": "3000204839", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "125 Blue Ball Rd", "city": "Elkton", "state": "MD", "postal_code": "21921-5315", "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.", "root_cause_description": "Process change control", "action": "The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it.\n\nBeginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows:\n\nCUSTOMER INSTRUCTIONS\nReview this Medical Device Recall Notice.\nAssure that all users receive notice of this issue.\nRefer to the Customer Response Form to identify your product that is subject to this action.\nConfirm receipt of this notification by completing and returning the attached Customer Response Form to\nthe email address or fax number indicated on the form .\nTerumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form.\nReturn all affected products to Terumo CVS.\n\nQUESTIONS?\nWe encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818\nMonday- Friday, 8 a.m . - 6 p.m. ET\nTerumo Safety Alert Fax: 1.410.392.7183\n Terumo Safety Alert Email: TCVSCustomerResponseElkton@terumomedical.com", "product_quantity": "297,222 units", "distribution_pattern": "Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan", "openfda": { 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