FDAFDA · Food and drugs·Recall number Z-1442-2020
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.
Published March 18, 2020 · Recall initiated: September 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CME America, LLC
- Distributor
- US: CA, OH, PA, and TX OUS: Canada
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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