Z-1474-2020Class I

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575...

Name: Z-1474-2020 CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575...
Creator: CME America, LLC
Published: 2020-01-07
License: https://open.fda.gov/license/

CME America, LLC / initiated 2020-01-07 / Terminated / root cause: design

FDA source

CME America, LLC began a recall of CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress on 2020-01-07. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1474-2020
Classification: Class I
Status: Terminated
Initiated: 2020-01-07
Posted: 2020-03-18
Terminated: 2022-04-14
Recalling firm: CME America, LLC
Product: CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Product code: FRN Pump, Infusion
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)
Root cause tag: design
FDA root cause: Device Design
Action: On 01/07/20, Urgent Medical Device Correction notices were emailed to distributors and mailed to direct customers. For direct customers, Recommendation on further product use included: The recalling firm recommends that customers continue to use the infusion pump system as per intended use. 1. As per standard clinical practice, clinicians administering infusions should assess the fluid container for volumes infused, volumes remaining in the container at the end of the infusion and ensure the total volume of prescribed medication is delivered. 2. Verify your maintenance records to confirm your pump is within one year of the last calibration. Where calibration has not occurred in the last 12 months, please contact your Authorized Service Provider to schedule a calibration as per the current Technical Service Manual. 3. Share this Letter with all users of the product within your facility to ensure awareness and understanding of these actions. The firm remains available for related support and clarification where needed. 4. Complete the attached Customer Response Form Contact Customer/Technical Support at 877-263-0111, Monday thru Friday from 9am to 5pm Mountain Time, for questions regarding this action. Actions Taken by the firm: The calibration instruction has been revised to implement tightened tolerance at plus/minus 1% (refer to Technical Service Manual rev. 10 for OP-12 and rev. 07 for OP-18) Beginning November 26, 2019 the final acceptance testing plan in manufacturing has been revised to include flow rate accuracy performance verification (plus/minus 5%) across the full range (minimum, nominal and maximum flow rates). In addition, distributors were asked to do the following: 1. Place a copy of the Customer Recall Letter in the materials that are distributed to customers with each pump manufactured prior to November 26, 2019. Distributors were asked to email a list of customers who received affected devices to the recalling firm, who wil
Quantity in commerce: 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
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1474-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1474-2020	Class I	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-18

Product code FRN

K061325Class IIBodygaurd Pain Manager Infusion SystemCaesarea Medical Electronics , Ltd. / cleared 2006-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)