The Recall Desk

FDA (Devices) recall action 66372

Hospira Inc. recalled 5 products on 2016-07-06

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2016-07-06
Critical
0
Units
11,762,796

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··2016-07-06

    Hospira Recalls LifeShield IV Sets Due to Potential Fluid Leakage

    Hospira is recalling approximately 3.9 million LifeShield IV administration sets because fluid may leak at the secondary port.

    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-06

    Hospira Recalls LifeShield IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific LifeShield IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    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…
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    Distribution
    0 states
  • HighFDA (Devices)··2016-07-06

    Hospira Recalls IV Administration Sets Due to Fluid Leakage Risk

    Hospira is recalling specific lots of Lifeshield IV administration sets because intravenous fluid may leak at the secondary port.

    Product
    *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    Product
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112…
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    0 states
  • SevereFDA (Devices)··2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.

    Product
    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode…
    Category
    Distribution
    0 states