Reported Jul 20, 2016 · Terminated
LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to…
Hospira Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes
- but is not limited to the followingmedical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics
- Lot codes and dates
- List No. 20709
- Serial Numbers
2,714 of 2,714 codes
155510011555100215551003155510041555100515551007155510091555101015551011155510121555101315551014155510151555101615551017155510181555101915551020155510211555102215551023155510241555102515551026155510281555102915551030155510311555103215551033155510341555103515551036155510371555103815551039155510401555104115551043155510441555104515551046155510471555104815551049155510501555105115551052155510531555105415551055155510561555105715551058155510591555106015551061155510621555106315551064
- Amount recalled
- 38,878 infusion pump systems
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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