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Recall Observatory FDA recall evidence

Device 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

Z-0305-2021

February 27, 2020

Class II

Product summary

Firm
CME America LLC
Event
Event 85479
Status
Terminated
Classification
Class II
Quantity
27 chargers
Official record key
device-enforcement:Z-0305-2021

Official wording

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

Code information: Catalog NO. 151-143XL LOT NO. 2019-0364

Distribution pattern: U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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