Recall Z-1886-2020— CME America, LLC

Name: FDA recall Z-1886-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-14

Class II · Terminated

Class II FDA medical device recall by CME America, LLC, initiated 2020-01-14, terminated 2021-05-27. It names one FDA 510(k) clearance: K031749. Product: 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: The filter installed onto the tube set may have the incorrect pore size..

Recalling firm: CME America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Terminated: 2021-05-27
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K031749 — BODYGUARD INFUSION SYSTEMCaesarea Medical Electronics , Ltd.·cleared 2003-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.