FDA-Device2015-04-29Class II
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Hospira Inc.
Hazard
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Sold states
Worldwide Distribution - US including 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, American Virgin Islands; and Internationally to Canada.
Affected count
8,214 units
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2015Don't want to check this manually?
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