{ "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": "104225", "product_res_number": "Z-0070-2012", "event_date_initiated": "2011-10-04", "event_date_posted": "2011-10-19", "recall_status": "Terminated", "event_date_terminated": "2012-03-14", "res_event_number": "60007", "product_code": "MJN", "k_numbers": [ "K051067" ], "product_description": "LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port\n\nThe Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the Shunt when it is placed within the common and internal carotid arteries. An external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal carotid balloon in the event it inflates above optimal size and pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage. The Pruitt F3 Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The sleeve of the external safety balloon is yellow, to increase its visibility. Depth markings on the shunt body are for reference during insertion", "code_info": "Lot Number: PFT2209", "firm_fei_number": "1220948", "recalling_firm": "Lemaitre Vascular, Inc.", "address_1": "63 2nd Ave", "city": "Burlington", "state": "MA", "postal_code": "01803-4413", "additional_info_contact": "Brian Kickham\n781-221-2266 Ext. 163", "reason_for_recall": "Extended Expiration on the outer box label 2016-05, the correct expiration date is on the tray label: 2014-05", "root_cause_description": "Incorrect or no expiration date", "action": "The firm, LeMaitre Vascular, Inc., sent an \"URGENT: 9F PRUITT F3 Carotid Shunt Device Field Safety Notice\" dated October 4, 2011 to its customers. The notice describes the product, problem and action to be taken. The customers were instructed to identify their inventory; return the affected products for exchange with a properly labeled device; contact Le Matire customer service for replacement at 800-628-9470, and complete and return the RECALL NOTICE RECONCILIATION FORM via fax to 781-425-5049, even if no product is on hand. \n\nIf you have any questions concerning this safety notice, please contact the Quality Assurance Engineer at 781-221-2266 ext. 183.", "product_quantity": "144 units", "distribution_pattern": "Nationwide distribution: USA including states of: CA, FL, IA, IL, MA, MI, NE, NJ, NY, OH, SC, TX, and WI.", "openfda": { "k_number": [ "K152762", "K092495", "K122576", "K172567", "K140273", "K960422", "K080861", "K955499", "K251358", "K062220", "K183679", "K193440", "K110903", "K170411", "K994141", "K093911", "K160067", "K033159", "K153530", "K141175", "K070770", "K011526", "K990487", "K192786", "K071367", "K023914", "K960715", "K132022", "K210358", "K143613", "K221294", "K211610", "K183045", "K053440", "K180904", "K131869", "K041306", "K080700", "K091504", "K021210", "K043023", "K010162", "K972777", "K110741", "K100063", "K200459", "K983802", "K003320", "K051067", "K915869", "K113698", "K191606", "K160598", "K011535", "K093847", "K172790", "K992942", "K081454", "K143454", "K152833", "K112219", "K011656", "K993248", "K001621", "K001917", "K182916", "K021066", "K203540", "K243795", "K103780", "K051137", "K052844", "K091458", "K201652", "K090728", "K121785", "K001237", "K210602", "K090970", "K212324", "K031357", "K960832", "K002286", "K993292", "K132990", "K101570", "K103356", "K214060", "K964390", "K142692" ], "registration_number": [ "3010432890", "3018565086", "1318694", "3007113487", "2011171", "1424778", "3010079067", "1018233", "1000121056", "3008853977", "3005994106", "3016257349", "3011279674", "1220948", "3045042524", "9618000", "2648045", "3012179728", "2032112", "3011660785", "3013556777", "3000126629", "3008881809", "9616684", "3012159165", "2124215", "3012497308", "3032916632", "2029386", "1048735", "3006082230", "3007284006", "3009756153", "3008816935", "1721676", "3015550451", "3026788751", "2183744", "1928237", "3014162263", "1319639", "3008114965", "3010173425", "2029214", "3005255160", "3009766315", "3004859241", "2135147", "3002807314", "9681260", "1724474", "3013944123", "3016842760", "3012279212", "3007628272", "3008627763", "2528981", "8023054", "2183982", "3016704395", "3007284313", "3008837339", "3015138222" ], "fei_number": [ "1000306647", "3010432890", "3018565086", "1318694", "3007113487", "1000138054", "2011171", "3010079067", "3003076831", "1000121056", "1018233", "3008853977", "3005994106", "3016257349", "3011279674", "1220948", "3045042524", "2648045", "3012179728", "3011660785", "3013556777", "3003245778", "3000126629", "1000220862", "3005334138", "3008881809", "1048735", "3009438986", "2124215", "3012159165", "3012497308", "3032916632", "3006082230", "1000116168", "3002913962", "3007284006", "3009756153", "3002806565", "3003473227", "1721676", "3015550451", "3003094851", "3026788751", "2183744", "1928237", "3014162263", "3004216185", "3008114965", "3005255160", "3009766315", "3004859241", "3002807314", "3013944123", "3002807036", "3016842760", "3012279212", "3007628272", "3008627763", "2528981", "3016704395", "3007284313", "3008837339", "3015138222" ], "device_name": "Catheter, Intravascular Occluding, Temporary", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4450", "device_class": "2" } } ] }