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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, and the hazard involves a risk of harm (fluid leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hospira Inc. is recalling approximately 3,920,932 units of LifeShield IV administration sets, including various PlumSet and SoluSet models. These products are used for intravenous fluid administration and feature a CLAVE secondary port for concurrent or piggyback infusion modes.
The recall was initiated because intravenous fluid may leak at the CLAVE secondary port of the affected sets. The source text does not report any specific illnesses or injuries associated with this defect.
The affected products were distributed nationwide in the United States. Users of these medical devices should contact their healthcare provider or Hospira for further instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Hospira Inc.
- 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 (1)
- X
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.
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