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U.S. Department of Health and Human Services

Class 2 Device Recall CMEAmerica BodyGuard Wall Charger

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  Class 2 Device Recall CMEAmerica BodyGuard Wall Charger see related information
Date Initiated by Firm February 27, 2020
Create Date October 29, 2020
Recall Status1 Terminated 3 on January 26, 2022
Recall Number Z-0305-2021
Recall Event ID 85479
510(K)Number K042696  
Product Classification Pump, infusion - Product Code FRN
Product CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/*

Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01,
CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA,
SM-0706 Rev 00

External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00

Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00
Code Information Catalog NO. 151-143XL LOT NO. 2019-0364
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		 The wall charger may not properly charge the infusion pump battery.
FDA Determined
Cause 2		 Employee error
Action On February 27, 2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" of wall charger, not charging the infusion pump, which could result in an unexpected low battery power. This could result in delay of medications and infusions. The firm instructed their customers to review their inventory.The firm will initiate contact with the customers via email and written letter by FedEx. A response form will be included for customer acknowledgement. The firm will request that distributors provide their customer list and the firm will notify those customers via FedEx mail. A customer response form is included with the letter to assist consignees in responding to the field action. The response forms will be reconciled with the customer list. The firm will make at least three attempts to follow up with all non-respondents via telephone, email or mail. The firm instructed their customers of the following actions: 1.Immediately review their inventory for the recalled devices, check the functionality of wall chargers, which displayed red light if functioning. Discard all non-functional wall chargers 2. Share this Urgent Medical Device Recall notice with all users of the product within your facility to ensure awareness of this action. 4.Complete the attached Customer Response Form and return it to the contact noted on the form regardless of whether the customers have any affected wall chargers or not so that the firm can acknowledge the receipt of this notification. 5. The firm asked customers to indicate on the response form the quantity of affected product identified at their facility and confirm that this inventory has been discarded. Credit or replacement product will be issued to customers for all discarded product. The firm will provide credit or replacements for all discarded inventory and provided the contact information as: Customer Support 303-936-4545 or 877-263-0111 toll free
Quantity in Commerce 27 chargers
Distribution U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".
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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