ClearanceBrief
510(k) K925126 ยท FPA Set, Administration, Intravascular

INTERLINK(TM) INJECTION SITE

ApplicantBaxter Healthcare Corp, Round Lake IL, US
DecisionSubstantially Equivalent, Jun 18, 1993
ReceivedOct 13, 1992
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K925126

DateFirm and productCodeLinked 510(k)
May 7, 2013Baxter Healthcare Corp.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in bl
Terminated
FPANone listed
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the
Terminated
FPANone listed
Jul 15, 2011Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per cas
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapt
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer Lock adapter with Re
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Health
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter; Baxter Healthcare
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Exte
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerf
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter H
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer
Terminated
FPANone listed
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter;
Terminated
FPANone listed
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A
Terminated
FPANone listed
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Aug 21, 2003Baxter Healthcare Corp.
Interlink System Solution Set with Microbore Tubing, 60 Drops/mL, 123'', 2 injection sites, Male Luer Lock Adapter, catalog 2C6426; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
FPANone listed
Aug 21, 2003Baxter Healthcare Corp.
Interlink System Vented Nitroglycerin Set, 104 '', PVC Tubing Segment, Injection Site, Male Luer Lock Adapter, catalog 2C7551; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Terminated
FPANone listed
Aug 21, 2003Baxter Healthcare Corp.
Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', 170 to 260 Micron Filter,Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C6723; Baxter Healthca
Terminated
KSBNone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set; catalog 1C8412; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set; catalog 1C8483; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546, Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577, Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332; Baxter Healthcare Corporation, Deerfield, IL 60015; 200 units per case
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333; Baxter Healthcare Corporation, Deerfield, IL 60015; 200 units per case
Terminated
FPANone listed
Jan 16, 2003Baxter Healthcare Corp.
Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corp
Terminated
KSBNone listed

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