—#122413

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K982159
Affected lot / code info: ***** 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 , 231825H ; *** 8) List Number: 19685-04-28; Lot Numbers: 682285H , 791285H , 850175H ; *** 9) List Number: 19720-04-28; Lot Numbers: 962305H , 092585H , 121635H , 180645H , 221715H , 260525H ; *** 10) List Number: 19721-04-28; Lot Numbers: 962315H, 132735H; *** 11) List Number: 19729-04-28; Lot Numbers: 032195H , 082285H , 121645H , 170415H , 200235H ; *** 12) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 13) List Number: 14951-04-48; Lot Numbers: 761875H , 761905H , 821525H , 830335H , 870625H , 870635H , 880125H , 051955H , 092565H , 142995H , 211715H , 231355H , 271495H , 281105H ; *** 14) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 15) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 16) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H

Why it was recalled

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Root cause (FDA determination)

Device Design

Action the firm took

Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: US (Nationwide) Distribution

Timeline

Recall initiated: 2013-09-09
Terminated: 2016-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122413. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.