ClearanceBrief
510(k) K811078 ยท FPA Set, Administration, Intravascular

RADIATION STERILIZED ADMIN. SET

ApplicantTravenol Laboratories, S.A., Mchenry IL, US
DecisionSubstantially Equivalent, Jul 2, 1981
ReceivedApr 20, 1981
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K811078

DateFirm and productCodeLinked 510(k)
May 7, 2013Baxter Healthcare Corp.
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol.
Terminated
FPANone listed
Oct 27, 2010Baxter Healthcare Corp.
Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock Adapter with Retractable Collar; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; pro
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4'', 0.4 mL Vol., with male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.3 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield,
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.9 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, I
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0'', 0.4 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.22 mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension s
Terminated
FMGNone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6
Terminated
FPANone listed
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporat
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Y-Type Minivolume Extension Set; catalog 1C8499; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y; Baxter Healthcare Corporation, Auto Syringe Division, Hookset, NH 03106
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M8527Y; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter AutoSyringe Extension Set with 0.22 Micron Filter, catalog 1M8529; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case
Terminated
FPANone listed
Feb 6, 2003Baxter Healthcare Corp.
Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case
Terminated
FPANone listed

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