FDA-Device2016-07-20Class II
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
Hospira Inc.
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.
Sold states
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:
Affected count
6,268 infusion pump systems
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2142-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief