Events

Recall of LIifeShield CLAVE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66372
  • Event Risk Class
    Class 2
  • Event Number
    Z-2058-2016
  • Event Initiated Date
    2013-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122209
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    Intravenous fluid may leak at the clave secondary port of hospira plumset iv administration sets.
  • 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.

Device

LIifeShield CLAVE
  • Model / Serial
    ***** 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 Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (Nationwide) Distribution
  • 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.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA