Z-1474-2020 Class I Terminated
FDA device recall Z-1474-2020 was initiated by CME America, LLC on January 7, 2020 and is designated Class I. Reason for recall: Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected dru… The recall status is terminated (terminated April 14, 2022). Affected quantity: 30,596 pumps.
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- April 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,596 pumps
Product Description
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Reason for Recall
Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)
Distribution Pattern
U.S.: HI, OR, AR, MA, PA, OH, WY, CO, NE, NC, WA, TX, UT, MD, CA, KY, FL, NH, TN, NY, SD, MO, IL, WI, MN, RI, VA, DC, SC, NJ, ME, KS, CT, MI, LA, AK, NM, IA, MT, ID, AZ, AL, VT, IN, MS
Code Information
All serial numbers