Reported Jul 20, 2016 · Terminated
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through…
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?
- The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
- Lot codes and dates
- List No. 1950
- Serial Numbers
3,619 of 3,619 codes
58151000210015100571006710087100951009610099101011010710109101111011210118101221012310125101281012910130101311013210134101361013710142101431014610148101491015110154101621016310164101651016710168101691017010171101721017410176101781017910180101811018210183101851018610187101881018910190101921019310194
- Amount recalled
- 53,151 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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