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

Recall Z-0718-2021 — APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

U.S. FDA — Device Enforcement · United States · 2020-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0718-2021
Date of alert
2020-11-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B Braun Medical, Inc.
Product category
device
Product type
Devices
Reported risk: There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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