Data Foundry

Medical device recalls 2020

CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364 — Class II medical device recall Z-0305-2021

Terminated recall by CME America LLC, reported 2020-11-04, distributed in IL, KS, MO. The wall charger may not properly charge the infusion pump battery.

Recall numberZ-0305-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCME America LLC, Golden, CO, United States
Recall initiated2020-02-27
Classified2020-10-29
Reported by FDA2020-11-04
Terminated2022-01-26
DistributedIL, KS, MO
Quantity27 chargers
Lot numbers01151143X, 151-143XL, 2019-0364
Model numbers01151143X, 151-143XL, 151-143XLP

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

Reason for recall

The wall charger may not properly charge the infusion pump battery.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0305-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.