510(k) K153440 ยท FPA Set, Administration, Intravascular
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Aug 18, 2016 |
| Received | Nov 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2020 | Becton Dickinson & Company PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 008 Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 0080174113 Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695) Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 0080 Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892) Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639) Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336),
0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 008017 Terminated |
PTI | None listed |
| Jul 20, 2020 | Becton Dickinson & Company SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-003 Terminated |
PTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.