Recall Z-1442-2020 ยท FRN Pump, Infusion
CME America, LLC
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
| Date | Mar 11, 2020 (initiated Sep 16, 2019) |
| Status | Terminated |
| Reason | When using a specific tubing set with infusion pump system, may result in under deliver of fluids. |
| Root cause | Nonconforming Material/Component |
| Action | Updated 10/7/2019: On 09/16/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via various methods (i.e., email, and written letter delivered by FedEx) along with a response form for customer acknowledgement. The notification informed customers, that all lots of its Microset tubing when used with their infusion pump system may under deliver fluids. The product was distributed beginning in October 2017. The firm is instructing customers to: 1. Immediately review their inventory for Catalog #A120-003XYVA and to discard all remaining inventory of the tube sets per |
| Quantity | 69400 infusion sets |
| Distribution | US: CA, OH, PA, and TX OUS: Canada |
| 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 |