510(k) K865060 ยท FRN Pump, Infusion
I.V. SET WITH DUAL-CHANNEL CASSETTE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 6, 1987 |
| Received | Dec 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2012 | Hospira Inc. LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number Terminated |
FRN | 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 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 |
| Jun 17, 2003 | Abbott Laboratories HPD/ADD Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064 Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.