CME America BodyGuard Infusion Pump System recall
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Why was CME America BodyGuard Infusion Pump System recalled?
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)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
- Recalling firm
- CME America, LLC
- Quantity
- 30,596 pumps
- Distribution
- 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
- Recall date
- March 25, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)