BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
Reported: May 13, 2020 Initiated: January 14, 2020 #Z-1886-2020
Product Description
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
Reason for Recall
The filter installed onto the tube set may have the incorrect pore size.
Details
- Recalling Firm
- CME America, LLC
- Units Affected
- 5,800 infusion sets from lot 90829 and 24,500 from lot 16201
- Distribution
- US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.
- Location
- Golden, CO
Frequently Asked Questions
What product was recalled? ▼
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.. Recalled by CME America, LLC. Units affected: 5,800 infusion sets from lot 90829 and 24,500 from lot 16201.
Why was this product recalled? ▼
The filter installed onto the tube set may have the incorrect pore size.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1886-2020.
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