ClearanceBrief
510(k) K832755 ยท FRN Pump, Infusion

INFUSION PUMP & IV SETS #4000

ApplicantOmni-Glow, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Nov 3, 1983
ReceivedAug 16, 1983
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K832755

DateFirm and productCodeLinked 510(k)
Apr 15, 2010Hospira Inc.
Latex-free. Midlength Secondary I.V. Set, convertible pin, 40 inch with extension hook for use with OMNI-FLOW Medication Management System and PLUM Series Infusions Systems, 15 drops/mL, a sterile Rx
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with secure lock for use with OMNI-FLOW medication management system,
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with orange polyethylene-lined/light resistant tubing and
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with inline cassette, collection bag, pre-pierced injection site and OPTION-LOK for use with
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with pre-pierced injection site and OPTION-LOK for use wit
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with high-pressure filter, orange polyethylene-lined/light
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressure-Activated Anti-Siphon Valve, convertible pin, 109 inch with CLAVE and OPTION-LOK for use OMNI-FLOW Medicati
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with CLAVE and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL,
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertible Pin, 72 Inch with 2 Pressure-Activated Anti-Siphon Valve, CLAVE and OPTION-LOK for use OMNI-FLOW, a sterile
Terminated
FPANone listed
Feb 8, 2006Hospira Inc.
LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
Terminated
FPANone listed
Jun 27, 2003Abbott 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
FPANone listed
Jun 27, 2003Abbott 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
FPANone listed
Jun 27, 2003Abbott 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
FRNNone listed
Jun 27, 2003Abbott Laboratories HPD/ADD
Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 15 different sets listed in the code information section below.
Terminated
FPANone listed
Jun 17, 2003Abbott 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
FPANone listed
Jun 5, 2003Abbott Laboratories HPD/ADD
LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port, product 19289
Terminated
FRNNone listed

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