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.
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jan 27, 2003 |
| Received | Jan 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.