{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 18 } }, "results": [ { "cfres_id": "188216", "product_res_number": "Z-2358-2021", "event_date_initiated": "2021-05-28", "event_date_created": "2021-08-27", "recall_status": "Open, Classified", "res_event_number": "88250", "product_code": "MSD", "k_numbers": [ "K111817" ], "product_description": "Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019", "code_info": "Lot Numbers:\n1733700175\n1806600076\n1828200123\n1930200088\n1800300146\n1814300196\n1828900141\n2012100137\n1805200088\n1822000084\n1829500128\n2027200247", "firm_fei_number": "1219930", "recalling_firm": "Covidien, LP", "address_1": "60 Middletown Ave", "city": "North Haven", "state": "CT", "postal_code": "06473-3908", "additional_info_contact": "Catherine Wrenn\n203-492-5000", "reason_for_recall": "This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).", "root_cause_description": "Labeling design", "action": "A Medical Device Market Withdrawal notification letter dated 5/28/21 was sent to customers.\n\nActions being taken by Medtronic\n1. Medtronic is developing point-of-use labeling reinforcing the important user assembly steps contained within the IFU related to the hub/back end assembly procedure.\n2. The IFU for Palindrome\" RT and Palindrome\" Precision RT chronic hemodialysis catheters will be updated to enhance the detailed instructions for users related to the steps required for hub/back end assembly.\n\nActions you should take\n1. Please immediately quarantine and discontinue use of affected item codes and lots listed in Attachment A.\n2. Please return affected product as indicated below. All unused products from the affected item codes and lots must be returned.\n3. If you have distributed the Palindrome\" RT and Palindrome\" Precision RT chronic hemodialysis catheters listed in Attachment A, please promptly forward the information from this letter to those recipients.\n4. Complete the Product Return Form even if you do not have inventory.\n\nPurchased directly from Medtronic\n1. Complete the Product Return Form and fax or email to Medtronic.\n2. Ship affected product with RGA number provided by Customer Service to:\nMedtronic\nAttn: Field Returns\n195 McDermott Road\nNorth Haven, CT 06473 USA\nFax to 800-895-6140 or email to rs.covidienfeedbackcustomerservice@medtronic.com\nCredit for returned affected product will\nbe issued based on the RGA number.\nException: Customers with zero inventory, fax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com\n\nPurchased from a distributor\n1. Complete the Product Return Form and fax or email to Medtronic\n2. Contact your distributor directly to arrange for return of product back to your distributor.\nFax to 651-367-2624 or email to rs.gmbfcamitg@medtronic.com\n\nThis action is being taken with the knowledge of the FDA and other regulatory authorities. We request that you contact Medtronic if you experienced a quality problem or adverse event.\n Ema", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K043272", "K012562", "K151967", "K981125", "K070572", "K971925", "K033676", "K141363", "K062671", "K140492", "K203575", "K030277", "K102043", "K111372", "K023847", "K131260", "K041006", "K994105", "K053589", "K190527", "K200627", "K040666", "K143567", "K040492", "K173805", "K020315", "K051748", "K101843", "K121933", "K032061", "K090528", "K040078", "K140884", "K011916", "K161026", "K100169", "K022678", "K111900", "K021212", "K010306", "K113487", "K130889", "K040509", "K073092", "K982326", "K042672", "K043292", "K141051", "K202176", "K040260", "K042858", "K110936", "K123196", "K022662", "K060288", "K042016", "K003207", "K210461", "K111817", "K013160", "K030983", "K040328", "K072499", "K010399", "K022000", "K063441", "K060972", "K051280", "K071202", "K203767", "K091760", "K040992", "K133796", "K111651", "K241581", "K030502", "K102238", "K982333", "K040318", "K022905", "K073093", "K111117", "K002902", "K030020", "K051584", "K211410", "K020465", "K131814", "K080400", "K041559", "K171571", "K001633", "K182443", "K090148", "K981365", "K092205", "K121848", "K972207", "K023023", "K071422", "K092597", "K063431", "K171618", "K130851", "K173667", "K012948", "K091506", "K060155", "K021759", "K033294", "K062901", "K123943", "K202150", "K032712", "K040736", "K981994", "K020936", "K130192", "K090101", "K040402", "K041914", "K012365", "K002901", "K010567" ], "device_name": "Catheter, Hemodialysis, Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "3010882065", "3030574705", "3008998256", "9610849", "3004111573", "1319639", "3011534620", "3015225571", "3016727301", "2518902", "1721504", "3011642792", "3015453963", "3015309643", "9617592", "1625425", "3006260740", "3019807891", "2020394", "3002807314", "3009211636", "1721676", "3004134316", "9611665", "3010041511", "3014461810", "2183744", "2030598", "3013750125", "1061124", "1833566", "3033589330", "3011137372", "3007137787", "3006950086", "3005987240", "2527072", "3007544634", "3013557562", "1282497", "1644312", "3035111606", "1018233", "3012050423", "1724474", "3003915875", "2030624", "2528981", "3006082230", "3012536737", "9680794", "1722746", "3015859709", "3017210488", "3008110587", "3006942602" ], "fei_number": [ "3030574705", "3008998256", "3006097687", "3004111573", "1000138054", "3011534620", "1000117748", "3015225571", "3016727301", "1000306216", "2518902", "3011642792", "3015453963", "3015309643", "1721504", "3006260740", "1625425", "3000206435", "3019807891", "2020394", "3002807314", "3009211636", "1721676", "3002468371", "3004134316", "3010041511", "3014461810", "2183744", "3005747797", "3013750125", "3033589330", "1000115408", "3002807391", "1000512168", "1000518731", "3007137787", "3002807095", "3006950086", "3005987240", "2527072", "3007544634", "3013557562", "1282497", "3035111606", "1018233", "3012050423", "3003915875", "2528981", "3006082230", "3012536737", "3003737899", "3015859709", "3017210488", "3008110587", "3006942602", "3003094851" ] } } ] }