Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2582-2020 — BodyGuard set with Female Luer, REF: A120-003XSN

U.S. FDA — Device Enforcement · United States · 2020-06-16 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2582-2020
Date of alert
2020-06-16
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
CME America, LLC
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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