Recall Z-2565-2020— CME America, LLC

Name: FDA recall Z-2565-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-16

Class I · Terminated

Class I FDA medical device recall by CME America, LLC, initiated 2020-06-16, terminated 2022-05-09. It names one FDA 510(k) clearance: K042696. Product: BodyGuard Microset, REF: A120-161XPSV. Reason: Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy.

Recalling firm: CME America, LLC
Classification: Class I
Status: Terminated
Initiated: 2020-06-16
Terminated: 2022-05-09
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: A120-161XPSV

Reason for recall

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

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