Skip to content
Recall Observatory FDA recall evidence

Device product

*** 1) 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; *** 2) 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; *** 3) 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; *** 4) 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: *** 5) 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; *** 6) 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.

Z-2062-2016

September 09, 2013

Class II

Product summary

Firm
Hospira Inc.
Event
Event 66372
Status
Terminated
Classification
Class II
Quantity
3,920,932 units in total
Official record key
device-enforcement:Z-2062-2016

Official wording

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

Code information: X

Distribution pattern: US (Nationwide) Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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