The Recall Desk
HighFDA (Devices)·Z-2061-2016·Announced 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.

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 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hospira Inc. is recalling specific lots of Lifeshield latex-free IV administration sets. The recall involves 3,920,932 units distributed nationwide in the United States and in Canada.

The recall was initiated because intravenous fluid may leak at the CLAVE secondary port of the affected sets. This port is used for secondary access during infusion.

Hospira is the recalling firm. The affected products are identified by specific list and lot numbers provided in the agency's structured data.

The recalled product

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 LATEX-F
Manufacturer
Hospira Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
3,920,932

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 (12)

  • ***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28
  • Lot Number: 133265H
  • ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04-28
  • Lot Numbers: 114405H
  • 143545H
  • 170385H
  • 170425H
  • 170395H
  • 210225H
  • 201655H
  • 260535H
  • 291595H

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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