*** 1) Product labeled in recall
*** 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…
Why was *** 1) Product labeled in recalled?
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
***** 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
- Product
- *** 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…
- Recalling firm
- Hospira Inc.
- Quantity
- 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units
- Distribution
- US (Nationwide) Distribution
- Recall date
- July 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)