FDA Device recall Z-2059-2016
*** 1) Product labeled in part: 14951-48
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of *** 1) Product labeled in part: 14951-48 by Hospira, citing intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2059-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-09 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
Product
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; *** 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
Reason
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Identifiers
| code_info | ***** US DISTRIBUTION ***** *** 1) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H ,…***** US DISTRIBUTION ***** *** 1) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 2) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 3) List Number: 19553-04-12; Lot Number: 751145H; *** 4) List Number: 19556-04-28; Lot Numbers: 750295H , 801115H , 900585H , 040145H , 143175H , 210195H , 281095H ; *** 5) List Number: 19557-04-28; Lot Numbers: 962435H , 040155H , 070705H , 071735H , 082165H , 091245H , 091255H , 091365H , 102515H , 200795H , 200945H , 210835H , 241705H , 280465H , 280475H , 240135H ; *** 6) List Number: 19671-04-28; Lot Numbers: 701785H , 730805H , 811605H , 861435H , 880255H ; *** 7) List Number: 19683-04-28; Lot Numbers: 782315H , 042125H , 211065H , 2318 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2016%22
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