Recall Z-0305-2021 ยท FRN Pump, Infusion
CME America LLC
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,
| Date | Feb 27, 2020 |
| Status | Terminated |
| Reason | The wall charger may not properly charge the infusion pump battery. |
| Root cause | 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 in |
| Quantity | 27 chargers |
| Distribution | U.S. Consignees: 3, IL, MO, KS OUS : 0 "No foreign consignees". |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042696 | BODYGUARD INFUSION PUMP SYSTEM Caesarea Medical Electronics , Ltd., Mar 11, 2005 |