Z-2058-2016Class II

*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter...

Name: Z-2058-2016 *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter...
Creator: Hospira Inc.
Published: 2013-09-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-09-09 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of *** 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)... on 2013-09-09. FDA classified it as Class II and gives the reason as "Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2058-2016
Classification: Class II
Status: Terminated
Initiated: 2013-09-09
Posted: 2016-06-29
Terminated: 2016-12-06
Recalling firm: Abbott Medical
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Root cause tag: design
FDA 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 [email protected]. 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 in commerce: 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units
Distribution: US (Nationwide) Distribution
Product codes and lots: ***** 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2059-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2060-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2061-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2062-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

Product code FPA

K103224Class IIHospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. / cleared 2011-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)