Class 1 Device Recall CME America BodyGuard Infusion Pump System

• Date Initiated by Firm: January 07, 2020
• Date Posted: March 18, 2020
• Recall Status: Terminated on April 14, 2022
• Recall Number: Z-1474-2020
• Recall Event ID: 85033
• 510(K)Number: K061325
• Product Classification: Pump, infusion - Product Code FRN
• Product: CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: CME America, LLC; 14998 W 6th Ave Ste 830; Golden CO 80401-5025
• For Additional Information Contact: 303-936-4945
• Manufacturer 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)
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = CAESAREA MEDICAL ELECTRONICS LTD.