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U.S. Department of Health and Human Services

Class 1 Device Recall CMEAmerica BodyGuard Microset

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  Class 1 Device Recall CMEAmerica BodyGuard Microset see related information
Date Initiated by Firm September 16, 2019
Date Posted March 11, 2020
Recall Status1 Terminated 3 on April 13, 2022
Recall Number Z-1442-2020
Recall Event ID 84985
510(K)Number K042696  
Product Classification Pump, infusion - Product Code FRN
Product BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml


Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
Code Information Catalog Number: A120-003XYVA UDI: 00818666020146  Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802 
Recalling Firm/
Manufacturer		 CME America, LLC
14998 W 6th Ave Ste 830
Golden CO 80401-5025
For Additional Information Contact
303-936-4545
Manufacturer Reason
for Recall		 When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Updated 10/7/2019: On 09/16/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via various methods (i.e., email, and written letter delivered by FedEx) along with a response form for customer acknowledgement. The notification informed customers, that all lots of its Microset tubing when used with their infusion pump system may under deliver fluids. The product was distributed beginning in October 2017. The firm is instructing customers to: 1. Immediately review their inventory for Catalog #A120-003XYVA and to discard all remaining inventory of the tube sets per their facility's guidelines 2. Share the Urgent Medical Device Recall notice with all users of the product with their facility to ensure awareness of this action. 3. Complete the attached Customer Response Form and return to the contact noted on the firm regardless of whether they have any affected material or not so that the Recalling Firm may acknowledge their receipt of the notification. Fax Number: 312-949-0333 or email to BDRC11@bd.comCustomer are to indicate on the response form the quantity of the tube sets remaining in inventory and confirm this inventory has been discarded. 4. Report any adverse health consequences experienced with the use of this product to the Recalling Firm. 5. Contact the Recalling Firm at 877-263-0111, Monday thru Friday from 9am to 5pm Mountain Time for a list of alternate sets that are available. Customer/Technical Support - 303-936-4545 or 877-263-0111 toll free.
Quantity in Commerce 69400 infusion sets
Distribution US: CA, OH, PA, and TX OUS: Canada
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.
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