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Hospira Inc. recalls The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/de
Recalled July 20, 2016 · FDA recall Z-2140-2016 · Hospira
Hazard
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. · FDA Class II
Units
8,216 infusion pump systems
Sold at
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
Description
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.
Product
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general 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.
Manufacturer(s)
Hospira Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →