510(k) K171957 · FPA Set, Administration, Intravascular

MaxZero Extension Sets with Needless Connector

Applicant	Carefusion 303, Inc., San Diego CA, US
Decision	Substantially Equivalent, Jul 19, 2017
Received	Jun 29, 2017
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K171957

Date	Firm and product	Code	Linked 510(k)
Apr 24, 2019	Centurion Medical Products Corporation PICC Line Accessory Kit CVI4285 Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation PEDIATRIC PICC INSERTION TRAY CVI4450 Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation PEDIATRIC PICC INSERTION TRAY CVI4450A Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535 Terminated	LRP	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE WITHOUT CATH CVI4600 Terminated	LRP	None listed
Apr 24, 2019	Centurion Medical Products Corporation PORT AND IO ACCESS DRESSING KIT DT15780A Terminated	OXQ	None listed
Apr 24, 2019	Centurion Medical Products Corporation Cap Change Kit DT20310 Terminated	OXQ	None listed
Apr 24, 2019	Centurion Medical Products Corporation Neonatal Cap Change Kit DT20315 Terminated	OXQ	None listed
Apr 24, 2019	Centurion Medical Products Corporation CAP CHANGE KIT DYNDC1496B Terminated	OXQ	None listed
Apr 24, 2019	Centurion Medical Products Corporation INFUSA PORT KIT DYNDC1840E Terminated	LRP	None listed
Apr 24, 2019	Centurion Medical Products Corporation INFUSA PORT KIT DYNDC1840F Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation STERILE CAP CHANGE KIT DYNDC1946B Terminated	OXQ	None listed
Apr 24, 2019	Centurion Medical Products Corporation CAP BUNDLE KIT DYNDC2137 Terminated	LRP	None listed
Apr 24, 2019	Centurion Medical Products Corporation TRIPLE LUMEN BUNDLE KIT ECVC1540 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE, 20CM, 4L, PI ECVC5095 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE, 20CM, 3L, PI ECVC5120 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE, 20CM, 3L, PI ECVC5120A Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CENTRAL LINE BUNDLE ECVC6375 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation OR VANTEX 7FR 3L 16CM CVC ECVC6665 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation IV START KIT IV8440 Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation IV SECUREMENT KIT IVS3405 Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation IV KIT - SORBAVIEW IVS3475 Terminated	LRS	None listed
Apr 24, 2019	Centurion Medical Products Corporation INVASIVE PROCEDURE TRAY MNS9510 Terminated	LRP	None listed
Apr 24, 2019	Centurion Medical Products Corporation TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040 Terminated	OES	None listed
Apr 24, 2019	Centurion Medical Products Corporation UVC TRAY UVT875 Terminated	LRP	None listed
Apr 10, 2019	Becton Dickinson & Company MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ80 Terminated	FPA	None listed

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