Reported Jul 20, 2016 · Terminated
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor,…
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 PCA 3 system cam be used in a wide range of clinical settings
- including but not limited togeneral floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia
- Lot codes and dates
- List No. 12384
- Serial Numbers
2,714 of 2,714 codes
129200411292004812920052129200561292006612920069129200791292008212920101129201021292010412920105129201061292010712920117129201211292012212920152129201581292015912920160129201741292024612920248129202511292025212920255129202571292026412920265129202681292027012920275129202761292027712920278129202821292028712920289129202911292029412920304129203051292031112920312129203201292032812920330129203321292034012920343129203461292034712920352129203531292035712920358129203591292036012920362
- Amount recalled
- 8,216 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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