510(k) K033576 ยท FPA Set, Administration, Intravascular
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Dec 4, 2003 |
| Received | Nov 13, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033576
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. Latex-free, Nitroglycerin, Midlength Secondary I.V. Pump Set, convertible pin, 40 inch with orange polyethylene-lined/light resistant tubing low absorption secondary set. For use only with OMNI-FLOW a Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Life shield Latex-Free Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with back check valve, 3 CALV ports, 0.2 micron filter, piggyback with OPTION-LOK, 15 drops/mL; a sterile Rx Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with backcheck valve, 3 CLAVE ports, piggyback with OPTION-LOK, 15 drops/mL, a sterile Rx single use device Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible pin, with backcheck valve, 3 CLAVE ports, piggyback with OPTION-LOK, and attached extension set, 15 drops/mL; a Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. 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 R Terminated |
FPA | None listed |
| Apr 15, 2010 | Hospira Inc. Lifeshield, latex-free, Y-Type Blood Set, yellow key slide clamp, 110 inch, nonvented with 170 micron filter, CLAVE port and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.