Z-0305-2021 Class II Terminated
FDA device recall Z-0305-2021 was initiated by CME America LLC on February 27, 2020 and is designated Class II. Reason for recall: The wall charger may not properly charge the infusion pump battery. The recall status is terminated (terminated January 26, 2022). Affected quantity: 27 chargers.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- February 27, 2020
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 chargers
Product Description
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.
Distribution Pattern
U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees".
Code Information
Catalog NO. 151-143XL LOT NO. 2019-0364