{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Lake Forest", "state": "IL", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "66372", "recalling_firm": "Hospira Inc.", "address_1": "275 N Field Dr", "address_2": "", "postal_code": "60045-2579", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US (Nationwide) Distribution", "recall_number": "Z-2058-2016", "product_description": "*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.", "product_quantity": "1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units", "reason_for_recall": "Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.", "recall_initiation_date": "20130909", "center_classification_date": "20160629", "termination_date": "20161206", "report_date": "20160706", "code_info": "***** US DISTRIBUTION ***** *** 1) List Number: 14212-04-28; Lot Numbers: 962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ; *** 2) List Number: 14254-08-28; Lot Number: 072055H; *** 3) List Number: 14687-04-28; Lot Numbers: 650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ; ***** FOREIGN DISTRIBUTION ***** *** 4) List Number: 12193-83-24; Lot Numbers: 662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ; *** 5) List Number: 12193-92-28; Lot Numbers: 063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ; *** 6) List Number: 19194-83-24; Lot Numbers: 662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ; *** 7) List Number: 19194-84-24; Lot Numbers: 881945H, 950975H; *** 8) List Number: 12194-92-28; Lot Numbers: 071105H , 140085H , 151445H , 180055H ; *** 9) List Number: 12195-83-24; Lot Numbers: 662105H , 712355H , 821545H , 880715H , 890745H , 910745H ; *** 10) List Number: 12195-84-24; Lot Numbers: 681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ; *** 11) List Number: 12195-92-28; Lot Numbers: 063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ; *** 12) List Number: 12196-83-24; Lot Numbers: 662125H , 702315H , 702325H , 712245H , 712255H ; *** 13) List Number: 12196-84-24; Lot Number: 871295H; *** 14) List Number: 12196-92-28; Lot Numbers: 071135H , 131835H , 151545H , 211645H , 250505H , 281575H ; *** 15) List Number: 14001-07-28; Lot Numbers: 810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ; *** 16) List Number: 14001-82-28; Lot Numbers: 890945H , 932935H , 151585H ; *** 17) List Number: 14001-83-28; Lot Numbers: 752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ; *** 18) List Number: 14001-84-28; Lot Numbers: 752254H , 830785H , 851515H , 890775H , 950355H ; *** 19) List Number: 14001-92-28; Lot Numbers: 063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ; *** 20) List Number: 14007-82-01; Lot Numbers: 811595H, 160345H; *** 21) List Number: 14007-92-28; Lot Numbers: 251485H, 270875H; *** 22) List Number: 14009-82-01; Lot Numbers: 811525H, 840885H, 910095H; *** 23) List Number: 14011-82-01; Lot Number: 811555H; *** 24) List Number: 14012-92-28; Lot Numbers: 162315H, 231615H; *** 25) List Number: 14013-82-01; Lot Numbers: 811535H, 840895H, 920855H; *** 26) List Number: 14014-92-28; Lot Number: 162305H; *** 27) List Number: 14015-82-01; Lot Numbers: 811515H, 910105H; *** 28) List Number: 14017-82-01; Lot Number: 811705H; *** 29) List Number: 14017-92-28; Lot Numbers: 112855H, 200955H; *** 30) List Number: 14022-92-28; Lot Numbers: 162325H, 172265H; *** 31) List Number: 14212-92-28; Lot Numbers: 071955H , 091685H , 100885H , 110505H , 113655H , 143425H , 161415H ; *** 32) List Number: 19673-53-24; Lot Numbers: 662035H , 701715H , 721575H , 910115H , 910515H , 961555H , 011455H , 031335H , 061995H , 102145H , 111615H , 132705H , 180615H , 201815H , 220725H , 200275H , 241365H", "more_code_info": "" } ] }