Hospira Recalls HemoSet IV Sets Due to Incorrect Lower Lid Component
Hospira is recalling 3,893 HemoSet IV sets because an incorrect lower lid was used during manufacturing, which changes the drop rate from 15 to 10 drops per mL.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a manufacturing defect that alters the drop rate (10 vs 15 drops/mL) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Hospira Inc. is recalling 3,893 units of LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. The affected product is identified by Product List Number 112410403 and Lot Numbers 280055H and 341005H. These sets are intended for the administration of blood and blood bags for use with Plum Series Infusers.
The recall was initiated because Hospira identified that an incorrect lower lid (set component) had been supplied and used during the manufacturing process. In a gravity delivery system, the correct lower lid dispenses 15 drops per mL, whereas the incorrect lower lid found in the affected units dispenses 10 drops per mL. This discrepancy affects the flow rate of the infusion.
The affected products were distributed in the United States, including the states of FL, IA, IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA, and WA. Healthcare facilities and consumers should check their inventory for the specific lot numbers and product list number listed above. If the product is found, it should be removed from use and returned to the supplier or Hospira Inc. according to their instructions.
The recalled product
- Product
- LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 3,893
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 (3)
- Product List Number: 112410403
- Lot Numbers: 280055H
- 341005H
Distribution
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