{ "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": "96273", "product_res_number": "Z-0865-2011", "event_date_initiated": "2010-12-10", "event_date_posted": "2011-01-06", "recall_status": "Terminated", "event_date_terminated": "2011-05-04", "res_event_number": "57457", "product_code": "LJS", "k_numbers": [ "K926331" ], "product_description": "Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116.\nThe Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.", "code_info": "Lot numbers: REUF1011, REUF1303.", "firm_fei_number": "3006260740", "recalling_firm": "Bard Access Systems", "address_1": "605 North 5600 West", "city": "Salt Lake City", "state": "UT", "postal_code": "84116-3738", "additional_info_contact": "801-522-5000", "reason_for_recall": "Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.", "root_cause_description": "Employee error", "action": "BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. \nCustomers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. \nAny remaining product was to be returned to Bard. \nFor information regarding this recall call 800-290-1689.", "product_quantity": "195 units", "distribution_pattern": "Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.", "openfda": { "k_number": [ "K953256", "K172899", "K232571", "K142889", "K131687", "K121941", "K082481", "K954720", "K241587", "K180548", "K172511", "K983412", "K953436", "K041468", "K851243", "K143238", "K093366", "K051690", "K921755", "K092306", "K883313", "K210264", "K844080", "K961336", "K180567", "K930630", "K932433", "K031129", "K050931", "K122423", "K061289", "K895543", "K897168", "K113277", "K150448", "K993052", "K840742", "K042491", "K112896", "K926293", "K012902", "K072196", "K093252", "K091953", "K023374", "K093927", "K161765", "K833442", "K120981", "K200037", "K964556", "K100635", 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