{ "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": 1 } }, "results": [ { "cfres_id": "174567", "product_res_number": "Z-0190-2020", "event_date_initiated": "2019-07-08", "event_date_created": "2019-10-24", "recall_status": "Terminated", "event_date_terminated": "2020-08-23", "res_event_number": "83286", "product_code": "LJT", "k_numbers": [ "K072657" ], "product_description": "GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: \n\n1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; \n\n2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; \n\n4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; \n\n5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; \n\n6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; \n\n7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; \n\n8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; \n\n9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; \n\n10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; \n\n11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; \n\n12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; \n\n13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; \n\n14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; \n\n15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; \n\n16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; \n\n17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; \n\n18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; \n\n22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; \n\n23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; \n\n24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; \n\n25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; \n\n26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; \n\n27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; \n\n28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; \n\n30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; \n\n31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; \n\n32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; \n\n33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; \n\n34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;", "code_info": "1. Item Number 21-4025-24, Lot Numbers 3674105, 3694006, 3712500, 3736641, 3748406, 3756975;   2. Item Number 21-4037-24, Lot Numbers 3659767, 3674101, 3690401, 3694005, 3703706, 3709205, 3731036, 3765362;   3. Item Number 21-4051-24, Lot Number: 3624979;   4. Item Number 21-4053-24, Lot Number 3659766, 3662933, 3731032;   5. Item Number 21-4055-24, Lot Numbers: 3683539, 3690396, 3690397, 3703705, 3709204, 3712498, 3717709, 3736577, 3748401, 3756973, 3765356, 3765357, 3765358, 3765360;   6. Item Number 21-4065-24, Lot Number: 3668869;   7. Item Number 21-4068-24, Lot Number: 3749691;   8. Item Number 21-4069-24, Lot Number: 3765354;   9. Item Number 21-4071-24, Lot Numbers: 3618196, 3740043;   10. Item Number 21-4073-24, Lot Numbers: 3687796, 3690395, 3731024, 3736575;   11. Item Number 21-4083-24, Lot Numbers: 3662930, 3662931, 3662932, 3756971, 3765346, 3765348;   12. Item Number 21-4153-24, Lot Numbers: 3628064, 3674098;   13. Item Number 21-4155-24, Lot Numbers: 3659764, 3674097, 3687795, 3717706, 3736572, 3776589;   14. Item Number 21-4171-24, Lot Numbers: 3696520, 3709202, 3772784;   15. Item Number 21-4183-24, Lot Numbers: 3731023, 3736569, 3756970;   16. Item Number 21-4187-24, Lot Numbers: 3756969, 3772751;   17. Item Number 21-4423-24, Lot Numbers: 3659762, 3662929, 3666142, 3756968, 3765344;   18. Item Number 21-4425-24, Lot Numbers: 3696519, 3717705, 3736566;   19. Item Number 21-4437-24, Lot Numbers: 3655263, 3666141, 3683517, 3694001, 3724970, 3730962, 3748385, 3748386, 3756965;   20. Item Number 21-4453-24, Lot Numbers: 3659761, 3662927, 3712497, 3730960, 3736565, 3748382, 3749695, 3765338;   21. Item Number 21-4455-24, Lot Numbers: 3643998, 3662926, 3666139, 3671489, 3674096, 3687793, 3690392, 3696517, 3703702, 3706172, 3712495, 3730957, 3736563, 3740039, 3748380, 3756963, 3772703;   22. Item Number 21-4465-24, Lot Numbers: 3655261, 3693997, 3736554;   23. Item Number 21-4471-24, Lot Numbers: 3703701, 3717695, 3717696, 3730951, 3730952, 3756958;   24. Item Number 21-4474-24, Lot Numbers: 3666137, 3765332;   25. Item Number 21-4475-24, Lot Numbers: 3655257, 3666126, 3709201, 3717694, 3736553, 3740036, 3756957, 3765329, 3765330;   26. Item Number 21-4476-24, Lot Numbers: 3655256, 3659759;   27. Item Number 21-4477-24, Lot Numbers: 3655255, 3674095, 3687791, 3690388, 3703700, 3706171, 3709200, 3719958, 3730948, 3740035, 3748373, 3756954;   28. Item Number 21-4483-24, Lot Numbers: 3655254, 3669980, 3679144, 3690385, 3690386, 3696515, 3703678, 3706170, 3730946, 3736551, 3740034, 3749697, 3756952;   29. Item Number 21-4485-24, Lot Numbers: 3679481, 3683507;   30. Item Number 21-4873-24, Lot Numbers: 3655242, 3659737, 3693996, 3706169, 3730945, 3748364, 3756946;   31. Item Number 21-8066-24, Lot Number: 3756945;   32. Item Number 21-8466-24, Lot Numbers: 3662921 ,3730943, 3756938;   33. Item Number 21-8468-24, Lot Numbers: 3659735, 3666104, 3765319;   34. Item Number 21-8470-24, Lot Numbers: 3655234, 3666103, 3696513, 3730942", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "763-383-3072", "reason_for_recall": "Potential for certain GRIPPER Needles to contain an occluded or blocked needle.", "root_cause_description": "Process control", "action": "Smiths Medical notified customers during the week of 07/08/2019 via \"URGENT MEDICAL DEVICE RECALL NOTICE\" letter. The Recall Notice advised customers that Smiths Medical has initiated a voluntary field removal for specific lots of GRIPPER needles and specific lots of PORT-A-CATH Trays containing GRIPPER needles. \n\nCustomers were instructed to examine inventory for affected product and complete and return the Response Form to GRIPPERocclusion2019@smiths-medical.com. Once the response form is received, Customer Service will provide a shipping label to return all affected product to Stericycle. A copy of the completed Response Form must be included inside EACH BOX of returned product to facilitate processing. Ensure boxes are sealed and labeled with your facility name prior to shipping. \n\nDistributors were instructed to immediately notify customers if the product was further distributed. A copy of the Recall Notice and accompanying Response Form should be included. \n\nQuestions regarding this notification can be sent to Smiths Medical via email at GRIPPERocclusion2019@smiths-medical.com.", "product_quantity": "3,952,509 devices total", "distribution_pattern": "Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR. \n\nInternational distribution", "openfda": { "k_number": [ "K870950", "K905842", "K875213", "K033686", "K964066", "K934802", "K022983", "K964538", "K260916", "K881075", "K994196", "K030636", "K122767", "K093414", "K190559", "K952537", "K973497", "K905851", "K952548", "K953529", "K070003", "K153359", "K871209", "K840481", "K915273", "K895871", "K953254", "K854019", "K921475", "K841150", "K090512", "K934518", "K953571", "K930206", "K924748", "K832917", "K091099", "K992880", "K153238", "K850888", "K896093", "K942623", "K934640", "K070116", "K881745", "K932095", "K921379", "K122834", "K863305", "K133335", "K832788", "K932841", "K934792", "K922896", "K032600", "K926011", "K905845", "K903691", "K924505", "K081472", "K974471", "K903364", "K952435", "K881342", "K934520", "K000125", "K081425", "K953073", "K151239", "K993024", "K952748", "K993860", "K964559", "K873213", "K942412", "K905841", "K994111", "K951872", "K122899", "K830730", "K994216", "K925373", "K073210", "K150514", "K050310", "K032008", "K932010", "K935767", "K961580", "K905850", "K873735", "K110424", "K932671", "K132177", "K050176", "K934167", "K961652", "K962751", "K954258", "K963684", "K232737", "K932840", "K971582", "K911355", "K951873", "K010767", "K923019", "K922419", "K905838", "K030083", "K002770", "K862018", "K181446", "K882230", "K942103", "K872838", "K933990", "K912702", "K932509", "K950131", "K942848", "K021580", "K841679", "K131694", "K924250", "K955819", "K942024", "K974829", "K905847", "K031282", "K010426", "K853322", "K870817", "K992697", "K921201", "K910005", "K920036", "K881256", "K932411", "K982888", "K942784", "K905843", "K961583", "K890518", "K082126", "K912423", "K974475", "K851293", "K951875", "K034065", "K904417", "K931748", "K251253", "K842355", "K062414", "K951076", "K875214", "K840788", "K973862", "K950212", "K921902", "K913350", "K071993", "K880297", "K951814", "K912540", "K905844", "K933316", "K934573", "K870187", "K841149", "K874184", "K150733", "K081889", "K853827", "K070911", "K991897", "K073423", "K870886", "K912424", "K953017", "K872898", "K122402", "K895030", "K871192", "K905848", "K072481", "K140169", "K933350", "K955407", "K903220", "K861498", "K905839", "K954433", "K905849", "K853332", "K983480", "K032557", "K905852", "K955587", "K945551", "K970442", "K072549", "K063377", "K910448", "K911449", "K101017", "K031844", "K961615", "K953110", "K933986", "K872329", "K043178", "K061424", "K870519", "K954297", "K033473", "K945752", "K962695", "K830000", "K072215", "K870260", "K905646", "K872149", "K894650", "K120281", "K960572", "K880571", "K891611", "K901722", "K932447", "K863750", "K880305", "K864349", "K951874", "K080645", "K882190", "K934796", "K974533", "K946189", "K003006", "K905846", "K032754", "K252478", "K141146", "K823838", "K945250", "K951077", "K895689", "K112713", "K936012", "K912465", "K922434", "K911055", "K022110", "K010189", "K922147", "K850967", "K905840", "K130576", "K853981", "K060812", "K102385", "K971140", "K875276", "K863296", "K873575", "K863723", "K934504", "K962230", "K032375", "K964117", "K901419", "K242328", "K072657", "K081311", "K864446", "K904077", "K893460", "K111101", "K960350", "K032044", "K153228", "K130923", "K926139", "K982507", "K110407", "K060036" ], "registration_number": [ "", "1319211", "3008537309", "3009888344", "3012494290", "1220905", "3007939342", "2245270", "3013666218", "3011534620", "3010149039", "3015859709", "3018094310", "3026560514", "2011171", "9617592", "3006260740", "1222928", "3042205359", "1061124", "3013750125", "1450392", "1048735", "9617604", "3006425876", "1000393132", "3010041511", "1219930", "3011237770", "2032112", "1018233", "3005704822", "3003700453", "2030624", "3007156625", "8020785", "1319639", "2518902", "2025816", "3013557562", "2246552", "9681202", "3015531529", "1223004", "9680794", "3004407880", "3009746061", "3006082230", "9611665", "3005232773", "3006942524", "3003678543", "3015537049", "3003915875", "3011088743", "1820334", "9612452", "1000523114" ], "fei_number": [ "", "1319211", "3008537309", "3009888344", "3012494290", "3003076831", "1000138054", "1220905", "3007939342", "2245270", "3013666218", "3011534620", "3010149039", "3015859709", "3018094310", "3026560514", "2011171", "3006260740", "3002468371", "3002806713", "3042205359", "3013750125", "1450392", "1048735", "3006425876", "1000393132", "1000120555", "3010041511", "1219930", "3011237770", "1018233", "3005704822", "3003700453", "1000512168", "3008737795", "3003737899", "2518902", "2025816", "3013557562", "2246552", "3015531529", "3002807095", "3004407880", "3009746061", "3009291251", "3006082230", "3005232773", "3006942524", "3003678543", "3015537049", "3003915875", "3011088743", "3002558692", "1820334", "1000120613", "3008133910", "3000206435", "1000523114" ], "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2" } } ] }