Device product
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.
Z-1442-2020
Product summary
- Firm
- CME America, LLC
- Event
- Event 84985
- Status
- Terminated
- Classification
- Class I
- Quantity
- 69400 infusion sets
- Official record key
device-enforcement:Z-1442-2020
Official wording
Reason: When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Code information: Catalog Number: A120-003XYVA UDI: 00818666020146 Lot Numbers: 10636 10653 12117 12836 13156 13279 13656 13978 14057 14188 14545 14790 14966 15073 19486 19490 19492 19834 16173 14966 15073 15277 15434 15802
Distribution pattern: US: CA, OH, PA, and TX OUS: Canada
Derived failure modes
-
Unknown
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.