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

Recall Z-3085-2024 — Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device

U.S. FDA — Device Enforcement · United States · 2024-08-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3085-2024
Date of alert
2024-08-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00085412475813
Reported risk: Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
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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