{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 98 } }, "results": [ { "cfres_id": "73319", "product_res_number": "Z-0021-2009", "event_date_initiated": "2008-08-11", "event_date_posted": "2008-10-02", "recall_status": "Terminated", "event_date_terminated": "2012-06-05", "res_event_number": "49435", "product_code": "GAM", "k_numbers": [ "K033746", "K944110", "K962480" ], "product_description": "VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP.\nEthicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876\n\nThe product is used for Soft Tissue approximation.", "code_info": "Product code V2920G, Lot ZE8KPMR0, Exp 6/30/2012; Product code PN1695H, Lot ZG8BDZQ0, Exp. 6/30/2012; Product code V2920H, Lot ZG8BJQR0, Exp 6/30/2012; Product code V4731H, Lot ZG8BSSQ0, Exp 6/30/2012; Product code VR214, Lot ZG8BTSD0, Exp. 6/30/2012; Product code W9947, Lot ZG8BHPQ0, Exp 6/30/2012; Product code VR214, Lot ZG9CJXD0, Exp. 6/06/2012; Product code V4851H, Lot ZG8BZWQ0, Exp. 6/30/2012 and  Product code VR426, Lot ZG9BSPE0, Exp. 6/4/2012.", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "US Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "Christiana Bielinski\n908-218-2553", "reason_for_recall": "Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.", "root_cause_description": "Packaging", "action": "Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.", "product_quantity": "6912", "distribution_pattern": "Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.", "openfda": { "k_number": [ "K060801", "K010672", "K980704", "K052437", "K180625", "K013671", "K150717", "K972566", "K181652", "K221527", "K091087", "K930588", "K252743", "K050845", "K120556", "K111442", "K173779", "K173043", "K093408", "K963253", "K042288", "K974299", "K200392", "K953869", "K962480", "K102592", "K141778", "K965162", "K033762", "K033746", "K013177", "K032586", "K041806", "K051415", "K142061", "K944937", "K930772", "K033115", "K031286", "K021767", "K060828", "K945285", "K232372", "K961997", "K040282", "K142822", "K081003", "K142810", "K062366", "K072644", "K990951", "K970317", "K073493", "K253852", "K080412", "K930746", "K161726", "K171494", "K000037", "K011375", "K072028", "K252820", "K141625", "K951520", "K143584", "K990432", "K944110", "K153611", "K151200", "K002190", "K173874", "K041515", 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"device_class": "2" } } ] }