ClearanceBrief
510(k) K030002 ยท FPA Set, Administration, Intravascular

LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.

ApplicantAbbott Laboratories, Abbott Park IL, US
DecisionSubstantially Equivalent, Jan 27, 2003
ReceivedJan 2, 2003
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K030002

DateFirm and productCodeLinked 510(k)
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free 150 mL Burette IV Set, yellow key slide clamp, microdrip, CLAVE Y-site, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 2
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, nonvented, 117 inch with pre-pierced injection site, ball check valve, backcheck valve, 2 CLAVE ports and removable 4-way high-flow stopcock and locking spi
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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, lis
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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, lis
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 113 inch with 2 pre-pierced injection sites and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 106 inch with backcheck valve and 3 pre-pierced injections sites, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hosp
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve and 2 pre-pierced injections sites, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospi
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 78 inch with pre-pierced injections sites with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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,
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake For
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback microdrip with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 2 CLAVE ports, piggyback with high-pressure filter and OPTION-LOK, 15 drops/mL, a sterile Rx single use devi
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve and 3 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake For
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 104 inch with nonphthalate (non-DEHP) tubing, CLAVE and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with backcheck valve, 3 CLAVE ports, piggyback MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc,
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Life shield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CALV and OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Homspera Inc, Lake Forest, IL USA. Made in Costa Rica, list
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 110 inch, 0.2 micron filter, CLAVE and OPTION-LOK, with nonphthalate (non-DEHP) tubing and PVC pump segment, 15 drops/mL, a sterile Rx single
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Latex-free, Primary I.V. Set, convertible pin, 82 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 19218-48.
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Set, convertible pin, 83 inch with backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Fore
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
CONTINUUM, Lifeshield, latex-free, Primary I.V. Set, convertible pin, 112 inch with removable 3-port pressure activated valve manifold, backcheck valve and 2 CLAVE ports, piggyback with OPTION-LOK, 15
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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 1
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Set, convertible pin, 110 inch with removable 3-port high-flow stopcock manifold, backcheck valve, and 2 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a ste
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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 Cost
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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; l
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
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.
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.