Class 1 Device Recall BodyGuard Microset

• Date Initiated by Firm: June 16, 2020
• Date Posted: July 15, 2020
• Recall Status: Terminated on May 09, 2022
• Recall Number: Z-2561-2020
• Recall Event ID: 85650
• 510(K)Number: K042696
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: BodyGuard Microset, REF: A120-160XYSF
• Code Information: All lots within expiry
• 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 administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
• FDA Determined Cause: Device Design
• Action: On 06/16/20, Urgent Medical Device Recall Correction and Removal notices were emailed and mailed to customers and distributors. These notices provided additional information about the administration sets that were first identified in another recall notification issued on 04/27/20: www.bd.com/en-us/support/recall-notifications/recall-notification---cme-america-bodyguard-infusion-pump-system Customers ere asked to take the following immediate actions: 1) Share this letter with all users of the product within your facility to ensure awareness and understanding of this notice. 2) Identify any remaining inventory of infusion sets in Category C and D, document the infusion sets on the Customer Response Form, and discard following your institution s policy for destruction. 3) Identify any remaining inventory of infusion sets in Category B and document that on the Customer Response Form. Labels stating, in part, do not use for flow rates greater-than 500mL/hr, will be provided upon receipt of response forms, so customers may affix them to those devices. The quantity of Category A sets should be noted on the response form. Category A sets can be used for non-critical medications where plus/minus 13% accuracy does not adversely impact patients. There is no flow rate restriction for these sets. The recalling firm is suspending further distribution of the infusion pump system until further notice and will remove these products from the U.S. market. The firm will work with customers to facilitate a smooth transition away from the product. A supply of infusion sets in Category A and Category B will be maintained to support the Infusion Pumps remaining at facilities until the removal or disposal of pump(s) is complete. Distributors were asked to email customer lists to the recalling firm so the recalling firm can notify these customers directly. Customers with additional questions were encouraged to call Customer/Technical Support at 877-263-0111 between 8AM to 5PM MDT.
• Quantity in Commerce: 50
• Distribution: U.S: CA, IN, LA, MO, FL, IL, ME, MN, CO, VA, OK, NE, GA, AL, KY, IA, MS, ID, TX, SC, OH, SD, NV, MI, WY, NC, PA, TN, KS, NJ, OR, AR, NM, MA, NY, DC, RI, MD, WA, WI, AZ, NH, UT, HI, AK, MT, ND, VT, CT. OUS (Foreign): Canada, UK
• 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 = FPA