ClearanceBrief
510(k) K941214 ยท FPK Tubing, Fluid Delivery

LIFESHIELD EXTENSION SET

ApplicantAbbott Mfg., Inc., Abbott Park IL, US
DecisionSubstantially Equivalent, Oct 3, 1994
ReceivedMar 10, 1994
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K941214

DateFirm and productCodeLinked 510(k)
Jan 11, 2017Hospira Inc.
Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Terminated
FPKNone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 100 inch with 2 pre-pierced injection sites, SOLUSET, MICRODRIP, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL
Terminated
FPANone listed
Nov 24, 2005Hospira 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
BRZNone listed
Nov 15, 2005Hospira 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
BRZNone listed
Nov 15, 2005Hospira 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
BRZNone listed
Nov 15, 2005Hospira 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
BRZNone 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
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
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 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

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