Hospira Inc. recalls The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within cl…

Recall date

February 27, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1517-2015

FDA classification

Class II

Brand / firm

Hospira Inc.

Sold / distributed

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; a…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.