Recall Z-1474-2020— CME America, LLC

Name: FDA recall Z-1474-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-07

Class I · Terminated

Class I FDA medical device recall by CME America, LLC, initiated 2020-01-07, terminated 2022-04-14. It names one FDA 510(k) clearance: K061325. Product: CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress. Reason: Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h).

Recalling firm: CME America, LLC
Classification: Class I
Status: Terminated
Initiated: 2020-01-07
Terminated: 2022-04-14
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K061325 — BODYGAURD PAIN MANAGER INFUSION SYSTEMCaesarea Medical Electronics , Ltd.·cleared 2006-08-24

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

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

Reason for recall

Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)

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