358 results
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Sources: EU EUDAMED, US FDA
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*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·March 12, 2014
Lifeshield, latex-free Secondary I.V. Set, convertible pin, 32 inch, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11953-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-free, Primary I.V. Set, vented, 78 inch with injection site, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1881-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-free, Primary I.V. Pump Set, convertible pin, 105 inch with 2 injection sites, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 3704-78.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3 CLAVE Y-sites, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; list 20802-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 20780-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 8962-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with CLAVE and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 13244-01.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3 pre-pierced Y-sites, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; list 20815-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free 170 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE Y-site, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 20806-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Y-Type Blood Set, nonvented, 100 inch with CLAVE and secure lock, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12450-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with OPTION-LOK and VENOSET, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12574-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with OPTION-LOK, non-DEHP, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12667-28.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, convertible pin, 83 inch, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 19321-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Latex-free, Nitroglycerin Primary I.V. Pump Set, convertible pin, 107 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11993-78.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free 210 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE Y-site, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 20805-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CLAVE ports and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 11960-68.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, MICRODRIP, backcheck valve, 2 CLAVE Y-sites, 60 drops/mL; a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; list 20779-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, backcheck valve, 2 CLAVE Y-sites,15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 20778-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, CLAVE Y-site, 15 drops/mL, a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica: list 20803-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009