Recall Z-1442-2020— CME America, LLC

Name: FDA recall Z-1442-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class I · Terminated

Class I FDA medical device recall by CME America, LLC, initiated 2019-09-16, terminated 2022-04-13. It names one FDA 510(k) clearance: K042696. 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.. Reason: When using a specific tubing set with infusion pump system, may result in under deliver of fluids..

Recalling firm: CME America, LLC
Classification: Class I
Status: Terminated
Initiated: 2019-09-16
Terminated: 2022-04-13
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K042696 — BODYGUARD INFUSION PUMP SYSTEMCaesarea Medical Electronics , Ltd.·cleared 2005-03-11

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 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.

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