FDA Medical Device Recalls (openFDA)

Hospira Inc.: * 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.

Recall number: Z-2058-2016
Recalling firm: Hospira Inc.
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; *** 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.
Status: Terminated
Initiated: 2013-09-09
Posted: not on file
Terminated: 2016-12-06
Reason: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Root cause: Device Design
Action: Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.
Quantity: 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units
Distribution: US (Nationwide) Distribution
Lot, serial or model codes: ***** 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
510(k) numbers: ["K103224"]
PMA numbers: not on file
Product code: FPA
Firm FEI: 3013319212
Firm city: Lake Forest
Firm state: IL
Firm country: not on file

Where this comes from

Register: FDA Medical Device Recalls (openFDA)
Publisher: U.S. Food and Drug Administration (openFDA)
File: device-recall-0001-of-0001.json.zip
sha256: b87518bfe2e8
Size: 288210821 bytes
Published: 2026-09-28
Read: 2026-09-29T08:25:23.626Z
Source file: Source file retained · verify
Refresh due: 2026-10-06

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FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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