The Recall Desk
HighFDA (Devices)·Z-2059-2016·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (fluid leakage) in a medical device, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Hospira Inc. is recalling specific LifeShield IV administration sets, including various PlumSet and Soluset models. The recall covers products distributed in the United States and Canada.

The recall is being conducted because intravenous fluid may leak at the CLAVE secondary port of the affected sets. The CLAVE secondary port is used as an easy secondary access point that allows for concurrent and piggyback mode in infusion, typically used with a syringe or a secondary IV infusion set.

Healthcare facilities and distributors should stop using the affected products. The source text does not specify the number of reported injuries or illnesses associated with this defect.

The recalled product

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 PLU
Manufacturer
Hospira Inc.
Category
Medical Device — IV Administration Sets
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • ***** 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · fluid leakage

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