510(k) K920736 ยท FPB Filter, Infusion Line
IVEX-HP96 EXTENDED LIFE FILTER SET
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Apr 23, 1993 |
| Received | Feb 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira Inc. 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 Terminated |
FPA | None listed |
| Nov 24, 2005 | Hospira Inc. LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration s Terminated |
BRZ | None listed |
| Nov 15, 2005 | Hospira Inc. LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 6004 Terminated |
BRZ | None listed |
| Nov 15, 2005 | Hospira Inc. LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; Hos Terminated |
BRZ | None listed |
| Nov 15, 2005 | Hospira Inc. LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; Hospira, Inc Terminated |
BRZ | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (li Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 95 different sets listed in the code information section below. Please not Terminated |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed i Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.