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.
Reported: March 18, 2020 Initiated: September 16, 2019 #Z-1442-2020
Product Description
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.
Reason for Recall
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Details
- Recalling Firm
- CME America, LLC
- Units Affected
- 69400 infusion sets
- Distribution
- US: CA, OH, PA, and TX OUS: Canada
- Location
- Golden, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CME America, LLC. Units affected: 69400 infusion sets.
Why was this product recalled? ▼
When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 18, 2020. Severity: Critical. Recall number: Z-1442-2020.
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